DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

D ISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION

300 River Place, Suite 5900 l/31/2022 - 3/18/2022*

Detroit, MI 48207 FEJNUMBER

1815692
(313) 393 - 8100 Fax: (313)393-8139

NAME AND mLE OF INDIVIDUAL TO WHOM REPORT ISSUED

TJ Hathaway, Site Director

FIRM NAME STREET ADDRESS

Abbott Laboratories dba Abbott Nutrition 901 N Centerville Rd

CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABUSHMENT INSPECTED

Sturgis, MI 49091-9302 Infant Formula Manufacturer

This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional
observations, and do not represent a final Agency determination regarding yotu· compliance. Ifyou have an objection regarding an
observation, or have in1plemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or
action with the FDA representative{s) during the inspection or submit this information to FDA at the address above. If you have any
questions, please contact FDA at the phone number and address above.

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

OBSERVATION 1
You did not establish a system of process controls covering all stages of processing that was designed to
ensure that infant fo1mula does not become adulterated due to the presence of microorganisms in the
fo1mula or in the processing environment.

Specifically,

A. FDA environmental samples collected on 2/1 /22-2/2/22 dming this inspection confinned the presence of
Cronobacter sakazakii on zone two and zone three surfaces in medium and high care areas of powdered
infant formula production, as indicated by finn management and Policy Document ANPPR06-003 "Zone
Definitions" (version 2.0, effective date 5/18/16) which defines low, medium, and high care areas.

Positive environmental sites for Cronobacter sakazaldi were as follows:

1. In the packaging room for filler line~ the hinge attachment and bolt heads on the top, clear cover
of the scoop hopper was swabbed and was positive for Cronobacter sakazaldi. This scoop hopper is
utilized to feed scoops, which are placed directly inside infant fo1mula containers and contact
product. This was collected from a zone two surface. You consider this a high care area. At the time

EMPLOYEE(S) SIGNATURE DATE ISSUED

SEE REVERSE Alexandra A Carrico, Investigator 3/18/2022

OF THIS PAG E John N Woodall, Investigator
Elizabeth P Mayer, National Expert
Danny Tuntevski, Investigator
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Christi L Bellmore, Investigator

Brittany A Mckenzie, Investigator
Daniel B Arrecis, Investigator
Rohn R Robertson, Inspector
Liliya V Bubiy, Investigator
Ana E Morales, Investigator
Nicholas E Boyd, Investigator
Adam M True, Investigator

FORM FDA ~83 (09/08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL OBSERVATIONS PAGE I of9 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION

300 River Place, Suite 5900 l/31/2022 - 3/18/2022*

Detroit, MI 48207 FEJNUMBER
1815692
(3 13) 393 - 8100 Fax: (3 13)393 - 8139

NAME AND mLE OF INDIVIDUAL TO WHOM REPORT ISSUED

TJ Hathaway, Site Director

F IRM NAME STREET ADDRESS

Abbott Laboratories dba Abbott Nutrition 901 N Centerville Rd

CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABUSHMENT INSPECTED

Sturgis, MI 4909 1 - 9302 Infant Formula Manu fact u rer

of swabbing, Similac Pro-Total Comfort with HMO infant formula powder (bate~ ) was
being packaged.

2. On the east side of the • - - -• the foot/base of a stmctural support piece of • · dryer f:J and the
immediate smrnunding floor was swabbed and was positive for Cronobacter sakazakii. This was
collected from a zone three surface. You consider this a medium care area. At the time of swabbing,
- dryer f:J was in a clean-in-place (CIP) cycle.

3. In the • Room on th~ ~ of • · dryer f:J there was duct tape on the floor;
debris was observed beneath and on top of the duct tape. The area between the duct tape and the wall
was swabbed and was positive for Cronobacter sakazakii; this area was directly across from the door
entry into the room. This was collected from a zone three surface. You consider this a medium care
area. At the time of swabbing • ' drye~ was in a CIP cycle.

4. ~.;;;;;,.,illir_.-.-. Room located on the • o~ drye1 · · the floor and the W>JQ]
• ~ door was swabbed and was positive for Cronobacter sakazakii. This was collected from a
zone three surface. You consider this a medium care area. At the time of swabbing, - dryer f:J
was in a CIP cycle.

B. Between 9/25/19 and 2/20/22, your firm's environmental samples and finished product testing confirmed
the presence of Cronobacter spp.

1. Environmental Samples: Your firm identified the presence of Cronobacter spp. in medium and high
care areas of powdered infant formula production through sampling on eight occasions between

EMPLOYEE(S) SIGNATURE DATE ISSUED

SEE REVERSE Alexandra A Carrico, Investigator 3/1 8/2022

OF THIS PAGE John N Woodall, Investigator
Elizabeth P Mayer, National Expert
Danny Tuntevski, Investigator
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Christi L Bellmore, Investigator

Brittany A Mckenzie, Investigator
Daniel B Arrecis, Investigator
Rohn R Robertson, Inspector
Liliya V Bubiy, Investigator
Ana E Morales, Investigator
Nicholas E Boyd, Investigator
Adam M True, Investigator

FORM FDA ~83 (09/08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL O BSERVATIONS PAGE 2 of9 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION

300 River Place, Suite 5900 l/31/2022 - 3/18/2022*

Detroit, MI 48207 FEJNUMBER
1815692
(3 13) 393 - 8100 Fax: (3 13)393 - 8139

NAME AND mLE OF INDIVIDUAL TO WHOM REPORT ISSUED

TJ Hathaway, Site Director

F IRM NAME STREET ADDRESS

Abbott Laboratories dba Abbott Nutrition 901 N Centerville Rd

CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABUSHMENT INSPECTED

Sturgis, MI 4909 1 - 9302 Infant Formula Manu fact u rer

10/10/19 and 2/2/22; two of those samples were taken during sister swabbing with the FDA. During
the root cause analysis initiated in response to FDA environmental samples collected on 2/1/22-
2/2/22 and your sister swabs collected on 2/1/22, your firm identified the presence of Cronobacter
spp. in low, medium, and high care areas of powdered infant formula production on 20 occasions
between 2/6/22-2/20/22.

2. Finished Product: Review of your firm's Non-Conf01mance Reports (NCRs) indicated that two
finished products tested positive for Cronobacter spp. as follows:

1. NCR • ~ (9/25/19) for Similac Alimennlll infant formula powder (batch IQ) (4) .
This powdered infant formula was dried on - dryerl l dry blended with xanthan gum, and
filled on filler line {]

11. NCR~ (6/22/20) for Similac for Spi- infant formula powder (batch ~ ).
This ~ ~ infant formula was dried on • · drye · dry blended with rice starch, and
filled on filler line #:

C . On 1/31/22, water was observed in the • · dr ' dryer was mnning Similac
Total Comfort infant formula powder (batch •
---=---..1
1. On the[UJIQI,
water was on the floor due to a leak from the inle _ ~ ~
This water was d r ~ from the valves onto the Ulillr.-~ floor. Per firm management, the leak
was the result of{_.!) A , which was compromised (Work Order #90361314).

Water events associated with the inlet • ~ were also reported on 2/1/21 (Work Order

EMPLOYEE(S) SIGNATURE DATE ISSUED

SEE REVERSE Alexandra A Carrico, Investigator 3/18/2022

OF THIS PAGE John N Woodall, Investigator
Elizabeth P Mayer, National Expert
Danny Tuntevski, Investigator
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Christi L Bellmore, Investigator

Brittany A Mckenzie, Investigator
Daniel B Arrecis, Investigator
Rohn R Robertson, Inspector
Liliya V Bubiy, Investigator
Ana E Morales, Investigator
Nicholas E Boyd, Investigator
Adam M True, Investigator

FORM FDA ~83 (09/08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL O BSE RVATIONS PAGE 3 of9 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION

300 River Place, Suite 5900 l/31/2022 - 3/18/2022*

Detroit, MI 4 8207 FEJNUMBER

1815692
(3 13) 393 - 8100 Fax : (3 13)393 - 8139

NAME AND mLE OF INDIVIDUAL TO WHOM REPORT ISSU ED

TJ Hat haway, Site Direct or

FIRM NAME STREET ADDRESS

Abbott Laborat ories dba Abbott Nutrition 901 N Centervi lle Rd

CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABUSHMENT INSPECTED

Sturgis, MI 4 9091 - 9302 I nfant Formula Manu fact u rer

#89251658), 11/4/21 (Work Order #90094256 and Work Order #90094248) and 1/21/22 (Work
Order #90329087).

2. On theWJIIIII, water was around the floor drain near the potassium hydroxide (KOH) tanks.

3. On theWJIIIII, water was at the floor/wall junction near the floor scrubber.
..,
4. In the basement, water was on the floor b the (b) (4) which was adjacent to the
(OJJCI]system of.,_•_ _ _ _ _____,

Standing water observed in powdered infant formula production areas is a repeat observation from
the FDA inspection dated 9/20/21-9/24/21.

D. From 1/1 /20-2/1/22, your fum identified 310 water events including water leaks, moisture and
condensation in chy powdered infant fo1mula production areas. These events do not include routine CIP
cycles of equipment in these areas.

OBSERVATION 2
You did not ensure that all surfaces that contacted infant fo1mula were maintained to protect infant
fo1mula from being contaminated by any source.

Specifically,

EMPLOYEE(S) SIGNATURE DATE ISSUED

SEE REVERSE Alexandra A Carrico, I nvestigat or 3/18 /2022

OF THIS PAGE John N Woodall, I nvestigat or
Elizabeth P Mayer, National Expert
Danny Tuntevski, I nvestigat or
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Christi L Bellmore, I nvestigat or

Brittany A Mckenzie, I nvestigat or
Daniel B Arrecis, I nvestigat or
Rohn R Robertson, I nspect or
Liliya V Bubiy, I nvestigat or
Ana E Morales, I nvestigat or
Nicholas E Boyd, I nvestigat or
Adam M True, I nvestigat or

FORM FDA ~83 (09/08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL OBSERVATIONS PAGE 4 of9 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION

300 River Pl a c e, Suite 5900 l /3 1 /2022 - 3/1 8/2022*

Detro it, MI 4 820 7 FEJNUMBER
1 8 1 5692
(31 3) 393 - 8 1 00 Fax: (31 3)393 - 8 1 39

NAME AN D mLE OF INDIVIDUAL TO WHOM REPORT ISSU ED

TJ Hath a way, S ite Direc t o r

F IRM NAME STREET ADDRESS

Abbott La borato rie s db a Abbott Nu trition 90 1 N Ce n tervi lle Rd

CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABUSHMENT INSPECTED

Sturg i s , MI 4 909 1 - 9302 I n fan t Fo r mu l a Man ufac turer

ha~ CIP cycles and from 12/31/ 19-2/6/22 • ' dryef""F. ha~ · CIP cycles. Dming the CIP cycle,
water is introduced into the ~ dryer environment. At the end of the CIP cycle, a "dry-out" step is
performed. Fo~ dry er #Jhe dry-out step is • ~ and forflTlil dr~ , the dry-out
step is • _ I
In addition, management stated that the dry out stepsfor I l!l dr·yers
were not validated to ensure complete drying is achieved.

B. Per your firm '{!!] dryer inspection reports • ' dryer • have a histo1y of internal
deterioration dating back to September 2018. The most recent • · d1yer inspections in Au13ust 2021
showed six instances of cracks and pits in the main chamber were recorded fo~ d1yer # and six
instances of cracks, pits and damage in the main chamber and were recorded for.
dryer ii
Ten cracked braces were also identified in the ~ - • fo1 • ' dryer · ·

Fmthe1more, both FDA and your firm found evidence of Cronobacter spp. in your powdered infant formula
production environment. Your firm also identified Cronobacter spp. in finished powdered infant fo1mula
products.

OBSERVATION 3
Y om investigation file on a complaint did not include the dete1mination as to whether a hazard to health
exists and the basis for that dete1mination.

Specifically,

A. During the inspection we followed-up on the following FDA consumer complaints, which were all
manufacnll'ed at your facility:

EMPLOYEE(S) SIGNATURE DATE ISSUED

SEE REVERSE Al e x a n dra A Carrico , I nve s tig ato r 3/1 8/2022

OF THIS PAGE J ohn N Woodall , I nve s tig ato r
El izab eth P Mayer, Nationa l Expert
Da nny Tun tevs ki, I nve s tig ato r
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, : ~12

Chri s ti L Be llmore, I nve s tig ato r

Brittan y A Mcke n zie, I nve s tig ato r
Da n ie l B Arrec i s , I nve s tig ato r
Rohn R Robert son , I nspe c t o r
Li l iya V Bubiy, I nve s tig ato r
An a E Moral e s , I nve s tig ato r
Ni chola s E Bo yd, I nve s tig ato r
Adam M Tru e, I nve s tig ato r

FORM FDA ~83 (09/08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL O BSE RVATIONS PAGE 5 of9 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION

300 River Pl a c e, Suite 5900 l/31/2022 - 3/18/2022*

Detro it, MI 4 820 7 FEJNUMBER
1815692
(313) 393 - 8100 Fax: (313)393 - 8139

NAME AN D mLE OF INDIVIDUAL TO WHOM REPORT ISSU ED

TJ Hath a way, S ite Direc t o r

F IRM NAME STREET ADDRESS

Abbott La borato rie s db a Abbott Nu trition 901 N Ce n tervi lle Rd

CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABUSHMENT INSPECTED

St u r g i s , MI 4 9091 - 9302 I n fan t Fo r mula Manufac t u rer

1. FDA Consumer Complaint # 171222 detailing a Cronobacter sakazakii illness and death associated
with 7 oz. Similac Pro-Total Comfo1t infant formula powder with batch # ro>mll(Abbott
Nutrition complaint ID: 554270)

2. FDA Consumer Complaint # 170177 detailing a Cronobacter sakazakii illness associated with 12.5
oz. Similac Sensitive infant formula powder with batch # ro>mll(Abbott Nutrition complaint
ID : 540628)

3. FDA Consumer Complaint # 171771 detailing a Cronobacter sakazakii illness associated with 12.4
oz. Similac Advance infant fo1mula powder with batch #WJIIIII
(Abbott Nutrition complaint
ID : 564946)

4. FDA Consumer Complaint # 17 1087 detailing a Salmonella newport illness associated with 19.8 oz.
Similac Alimentum infant formula powder with batch # II!) ~ (Abbott Nutr·ition complaint ID:·7
564943)

Your complaint investigations did not identify the root causes of the Cronobacter sakazakii and
Salmonella ne,vport illnesses reported from these complaints. Additionally, your complaint
investigations tr·eated infant death and infant illness the same.

B. Your Standard Operating Procedure (SOP) AN04-0l -001 "Complaint Management and Investigations"
(version 25, effective date 2/28/21 and version 26, effective date 12/21/21 ) states that retained samples
are evaluated for microbial analysis in the following circumstances:

EMPLOYEE(S) SIGNATURE DATE ISSUED

SEE REVERSE Al e x a n dra A Carrico , I nve s tig ato r 3/1 8/2022

OF THIS PAGE J ohn N Woodall , I nve s tig ato r
El izab eth P Mayer, Nationa l Expert
Da nny Tuntevs ki, I nve s tig ato r
X
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8trieo:9/:~Ac.rco •
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, : ~12

Chri s ti L Be llmore, I nve s tig ato r

Brittan y A Mcke n zie, I nve s tig ato r
Da n ie l B Arrec i s , I nve s tig ato r
Rohn R Robert son , I nspe c t o r
Li l iya V Bubiy, I nve s tig ato r
An a E Moral e s , I nve s tig ato r
Ni chola s E Bo yd, I nve s tig ato r
Adam M Tru e, I nve s tig ato r

FORM FDA ~83 (09/08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL O BSERVATIONS PAGE 6 of9 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION

300 River Pl a c e, Suite 5900 l /3 1 /2022 - 3/1 8/2022 *

FEJNUMBER
Detro it, MI 4 820 7
1 8 1 5692
(313) 393 - 8 1 00 Fax: (3 1 3)393 - 8 1 39

NAME AN D mLE OF INDIVIDUAL TO WHOM REPORT ISSU ED

TJ Hath a way, S ite Direc t o r

F IRM NAME STREET ADDRESS

Abbott La borato rie s db a Abbott Nu trition 90 1 N Ce n tervi lle Rd

C ITY. STATE. Z IP CODE. COUITTRY TYPE ESTABUSHM ENT INSPECTED

St u r g i s , MI 4 909 1 - 9302 I n fan t Fo r mula Manufac t u rer

1. "When requested by Medical Safety and Surveillance for specific cases for Adverse Events
(including Adverse Event trends) detennined on a case by case basis (such as Cronobacter species,
food poisoning, bacte1ial contamination, infection, etc.)"

2. "When it is dete1mined during the course of the complaint investigation that there is a potential for
the distributed product not to comply with specifications. "

On 1/31/22, your film provided the Complaint Detail Repo1t with the stan1s "Closed-Done" for FDA
Consumer Complaint # 171222 (Abbott Nutrition complaint ID: 554270) detailing a Cronobacter
sakazakii illness and death associated with 7 oz. Similac Pro Total Comfo1t infant fo1mula powder with
batch # [l!l ~ I
During the investigation of this complaint, the Abbott Nutrition Medical Safety and
Surveillance (ANMSS) team did not request that retain samples be tested for this lot in accordance with
SOP AN04-0l -001 "Complaint Management and Investigations". The final medical and quality
assessments for this Complaint Detail Repo1t were signed on 1/5/22.

OBSERVATION 4
Personnel working directly with infant fo1mula, its raw materials, packaging, or equipment or utensil
contact smfaces did not wear necessary protective apparel.

Specifically,

A. On 1/31/22, iI].~ ·yer(mm we observed an employee exit the elevator and enter the room with
the I I!) ~ , passing by a shoe spray station and failing to spray the soles of their shoes with

EMPLOYEE(S) SIGNATURE DATE ISSUED

SEE REVERSE Al e x a n dra A Carrico , I nve s tig ato r 3/1 8/2022

OF THIS PAGE J ohn N Woodall , I nve s tig ato r
El izab eth P Mayer, Nationa l Expert X
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8trieo:9/:~Ac.rco•
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Da nny Tuntevs ki, I nve s tig ato r

Chri s ti L Be llmore, I nve s tig ato r
Brittan y A Mcke n zie, I nve s tig ato r
Da n ie l B Arrec i s , I nve s tig ato r
Rohn R Robert son , I nspe c t o r
Li liya V Bubiy, I nve s tig ato r
An a E Moral e s , I nve s tig ato r
Nichola s E Bo yd, I nve s tig ato r
Adam M Tru e, I nve s tig ato r

FORM FDA ~83 (09/08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL OBSERVATIONS PAGE 7 of9 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION

300 River Place, Suite 5900 l/31/2022 - 3/18/2022*

Detroit, MI 4 8207 FEJNUMBER
1815692
(3 13) 393 - 8100 Fax: (3 13)393 - 8139

NAME AND mLE OF INDIVIDUAL TO WHOM REPORT ISSUED

TJ Hat haway, Site Direct or

F IRM NAME STREET ADDRESS

Abbott Laborat ories dba Abbott Nutrition 901 N Centervi lle Rd

CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABUSHMENT INSPECTED

St u rgis, MI 4 9091 - 9302 I nfant Formula Manu fact u rer

sanitizer. At the same time this was observed, the nozzle of the sanitizer bottle was set to stream instead
of spray while other individuals were spraying the soles of their shoes, which did not allow a unifonn
coating of sanitizer on the soles of shoes. This was observed while- dryer ti was running Similac
Total Comfort infant formula powder (batch ~ -

B. On 2/24/22, your firm provided a draft root cause analysis dated 2/8/22 in response to the FDA
environmental samples collected on 2/1/22 -2/2/22 and your sister swabs collected on 2/1/22 . You then
provided an explanation of the root cause analysis, stating that fr~m 1/24/22-2/9/22 ~e;gximately, .
contractors were present at the firm to perform work in Buildin{:J primarily in the dryel E..::1
• • . The contractors walked on the roof with their captive footwear; upon returning into the building,
they did not sanitize nor change their shoes.

These actions do not comply with your SOP ST-1000.08 "Dress Code and Personal Hygiene" (version
58, effective date 11/5/21), which states that "Contractors shall bag outdoor non-captive safety shoes and
walk them to the designated shoe changing areas to change from captive safety shoes to non-captive
safety shoes. Upon re-entering the plant, the process will reverse in order and outdoor non-captive shoes
will be bagged and returned to their designated cubby or storage location."

FUithe1more, the FDA found evidence of Cronobacter sakazakii in- dryer l!1 ·~ I from
environmental samples collected on 2/1/22 . Your firm found evidence of Cronobacter spp. in • • dryer
(tiJJCI] from your sister swabs collected on 2/1/22 and your vector swabbing conducted dunng your
root cause analysis.

C . On 1/31/22-2/4/22 and 2/8/22, we observed employees wearing their captive shoes walking in hallways,

EMPLOYEE(S) SIGNATURE DATE ISSUED

SEE REVERSE Alexandra A Carrico, I nvestigat or 3/1 8/2022

OF THIS PAGE John N Woodall, I nvestigat or
Elizabet h P Mayer, National Expert
Danny Tuntevski, I nvestigat or
X
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8trieo:9/:~Ac.rco•
g.,_._0>1•2022
, : ~12

Christi L Bellmore, I nvestigat or

Brittany A Mckenzie, I nvestigat or
Daniel B Arrecis, I nvestigat or
Rohn R Robertson, I nspect or
Liliya V Bubiy, I nvestigat or
Ana E Morales, I nvestigat or
Nicholas E Boyd, I nvestigat or
Adam M True, I nvestigat or

FORM FDA ~83 (09/08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL O BSE RVATIONS PAGE 8 of9 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
D ISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION

300 River Pl a c e, Suite 5900 l/31/2022 - 3/18/2022*

Detro it, MI 4 820 7 FEJNUMBER
1815692
(313) 393 - 8100 Fax: (313)393 - 8139

NAME AN D mLE OF INDIVIDUAL TO WHOM REPORT ISSU ED

TJ Hath a way, S ite Direc t o r

F IRM NAME STREET ADDRESS

Abbott La borato rie s db a Abbott Nu trition 901 N Ce n tervi lle Rd

CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABUSHMENT INSPECTED

St u r g i s , MI 4 9091 - 9302 I n fan t Fo r mula Manufac t u rer

the cafete1ia, and exiting the restroom. Between 1/31/22-2/12/22 employees, visitors, and contractors
were not required to spray their captive shoes with sanitizer before enteling the production area.

*DATES OF INSPECTION
1/31/2022(Mon), 2/01/2022(Tue), 2/02/2022(Wed), 2/03/2022(Thu), 2/04/2022(Fri), 2/08/2022(Tue),
2/1 6/2022(Wed), 2/1 7 /2022(Thu), 2/1 8/2022(Fri), 2/21/2022(Mon), 2/22/2022(Tue), 2/23/2022(Wed),
2/24/2022(Thu), 2/25/2022(Fri), 2/28/2022(Mon), 3/02/2022(Wed), 3/03/2022(Thu), 3/09/2022(Wed),
3/1 0/2022(Thu), 3/1 4/2022(Mon), 3/1 5/2022(Tue), 3/16/2022(Wed), 3/1 7 /2022(Thu), 3/1 8/2022(Fri)

John N Woodall
~~John N. Woodal-S
X Oate- Signed: 03-18--2022 14:50:13

EMPLOYEE(S) SIGNATURE DA TE ISSUED

SEE REVERSE Al e x a n dra A Carrico , I nve s tig ato r 3/18 /2022

OF THIS PAGE J ohn N Woodall , I nve s tig ato r
El izab eth P Mayer, Nationa l Expert
Da nny Tuntevs ki, I nve s tig ato r
X
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8trieo:9/:~Ac.rco •
g.,_._ 0>1•2022
, : ~12

Chri s ti L Be llmore, I nve s tig ato r

Brittan y A Mcke n zie, I nve s tig ato r
Da n ie l B Arrec i s , I nve s tig ato r
Rohn R Robert son , I nspe c t o r
Li l iya V Bubiy, I nve s tig ato r
An a E Moral e s , I nve s tig ato r
Ni chola s E Bo yd, I nve s tig ato r
Adam M Tru e, I nve s tig ato r

FORM FDA ~83 (09/08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL OBSERVATIONS PAGE 9 of9 PAGES
The observations of objectionable conditions and practices listed on the front of this form
are reported:
1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or
2. To assist firms inspected in complying with the Acts and regulations enforced by the
Food and Drug Administration.

Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 374(b)) provides:

"Upon completion of any such inspection of a factory, warehouse, consulting

laboratory, or other establishment, and prior to leaving the premises, the officer or
employee making the inspection shall give to the owner, operator, or agent in charge a
report in writing setting forth any conditions or practices observed by him which, in his
judgment, indicate that any food, drug, device, or cosmetic in such establishment (1)
consists in whole or in part of any filthy, putrid, or decomposed substance, or (2) has
been prepared, packed, or held under insanitary conditions whereby it may have become
contaminated with filth, or whereby it may have been rendered injurious to health. A copy
of such report shall be sent promptly to the Secretary."