Timeline of infant formula related activities 1

• 11 March 2020 – World Health Organization declares COVID-19 a pandemic.

• 16 March 2020 – FDA begins to have concerns about infant formula and special medical food

shortages given their production at a small number of facilities controlled by a handful of firms. FDA

identifies a need for supply chain authorities and begins to draft a legislative proposal.

• 21 March 2020 – FDA submits a legislative proposal to Congress requesting supply chain authority for

infant formula and special medical foods.

• September 2020 – FDA stands up a proof-of-concept food supply chain monitoring system called

21 Forward to monitor the food supply chain for disruptions despite lack of dedicated funds or

authorities. FDA initially uses the system to monitor for supply chain disruptions related to COVID-19,

including infant formula-related disruptions. For example, we contacted an infant formula plant in a

COVID rapid riser community in an attempt to minimize disruption.

• June 2021 – FDA requests infant formula and special medical food supply chain authorities in its FY

2022 budget request. FDA also requests funding for four additional infant formula staff.

• 20 – 24 September 2021 – FDA conducts a routine surveillance inspection at Abbott Nutrition’s

Sturgis, Michigan, facility. The FDA investigator searched the Agency’s database for related consumer

complaints days prior to inspection. FDA made five observations – including standing water and 

inadequate handwashing.1

• 20 September 2021 – FDA receives a consumer complaint report of Cronobacter illness in an infant 

from the Minnesota Department of Health (Case Complaint #1). The illness onset was

6 September 2021.

• 21 September 2021 – FDA informs Abbott Nutrition of the Cronobacter complaint it received (Case

Complaint #1). Minnesota Department of Health sent product samples to CDC for sequencing earlier

in September.

• 23 September 2021 – FDA collects product samples from the hospital where the patient was treated.

The sample was sent to FDA’s Southeast Food and Feed Laboratory for analysis (Case Complaint #1).

• 6 October 2021 – FDA’s Southeast Food and Feed Laboratory reports no Cronobacter findings in 

samples (Case Complaint #1).

• 10 October 2021 – Minnesota Department of Health sends patient clinical sample to CDC (Case

Complaint #1). 

1 U.S. Food and Drug Administration, “Form 483: Inspectional Observations; Abbott Nutrition, Sturgis, Michigan Facility,” September 

20-24, 2021, available at https://www.fda.gov/media/156747/download?utm_medium=email&utm_source=govdelivery.

Timeline of infant formula related activities

 2020

 2021
2 Timeline of infant formula related activities

• 21 October 2021 – FDA receives a complaint from a confidential informant electronically. Complaint is

reviewed by multiple FDA staff. FDA acknowledges receipt. FDA begins planning for an inspection at

Abbott Nutrition’s Sturgis facility.

• 26 October 2021—FDA Detroit District Office receives a hard copy of a complaint from a confidential

informant. FDA leadership do not receive direct copies of the complaint due to an isolated failure in

FDA’s mailroom, likely due to COVID-19 staffing issues.

FDA Staff in Receipt of Complaint; Dates of Receipt

William Weissinger (Office of Human and Animal 

Food Operations-East Division 6, District 

Director, Office of Regulatory Affairs (ORA)

21 October 2021 – Received via email

26 October 2021 – Received via FedEx

Dr. Andrea Lotze (Medical Director, Infant 

Formula and Medical Foods Staff, CFSAN) 

20 October 2021 – Received via email* 

Cathy Hermsen (Assistant Commissioner for 

Criminal Investigations, ORA) 

3 November 2021 – Alerted to existence by FDA 

staff

5 November 2021 – Received via USPS (FEDEX 

package with complaint)

Dr. Judith McMeekin (Associate Commissioner 

for Regulatory Affairs) 

14 February 2022 – Received via email 

(forwarded from FDA staff)* 

Dr. Susan Mayne (Director, CFSAN) 14 February 2022 – Received via email*

Dr. Janet Woodcock (then-Acting FDA 

Commissioner) 

14 February 2022 – Received via email 

(forwarded from FDA staff)* 

*Hard copies addressed to these individuals were not forwarded from the FDA mailrooms, likely due

to COVID-19-related mail routing issues. In May 2022, the CFSAN mailroom located copies of the

complaint sent to Susan Mayne and Andrea Lotze vie FedEx and forwarded to these individuals. The

copies of the complaint sent via FedEx to Judith McMeekin and Janet Woodcock have not been

located to date but a mailroom analysis is underway.

• 4 November 2021 – FDA Office of Human and Animal Food Operations (OHAFO) staff discuss 

confidential informant complaint with FDA’s Office of Criminal Investigations.

• 8 November 2021 – FDA OHAFO staff discuss confidential informant complaint with the investigator 

and National Expert Investigator (whose expertise includes infant formula and medical food

inspections) who inspected Sturgis facility in September 2021.

• 17 November 2021 – FDA receives a consumer complaint of a Salmonella illness potentially

associated with an Abbott Nutrition powdered infant formula. After investigation, CDC and FDA

eventually rule this case as unrelated to Abbott Nutrition.

• 1 December 2021 – FDA receives a consumer complaint of a Cronobacter death potentially

associated with Abbott Nutrition powdered infant formula (Case Complaint #2). The date of illness

onset was 20 November 2021. No positives for Cronobacter were among formula samples collected

by FDA for follow-up testing.

• 2 December 2021 – FDA notifies Abbott Nutrition of the Salmonella and second Cronobacter

consumer complaints (as previously noted, FDA and CDC later decide the Salmonella case is not

related to Abbott Nutrition). FDA collected and analyzed product samples but did not find Cronobacter

or Salmonella. No clinical isolate was available for the Cronobacter case.

• 7 December 2021 – FDA requests to interview the confidential informant, but due to scheduling 

limitations associated with the informant, the interview was not scheduled until 22 December 2021. 
Timeline of infant formula related activities 3

• 22 December 2021 – FDA interviews the confidential informant. This information informs the

inspection that occurs in January 2022.

• 30 December 2021 – FDA contacts Abbott Nutrition to schedule a 3 January 2022 inspection

pursuant to the Agency’s policy to preannounce inspections during the COVID-19 pandemic. Abbott

Nutrition requests FDA delay the inspection due to an ongoing COVID-19 outbreak among its staff.

FDA agrees to a delay.

• 11 January 2022 – FDA receives a third Cronobacter illness complaint (Case Complaint #3). The date 

of illness onset was 18 December 2021. Samples collected by the Texas Department of State Health 

Services do not test positive for Cronobacter. This is the second case with a clinical isolate sample 

available for comparison to environmental samples that will be taken during FDA’s inspection later this 

month at the Sturgis facility.

• 27 January 2022 – FDA contacts Abbott Nutrition to announce our intention to proceed with an

inspection. Abbott Nutrition informs FDA of a continued COVID-19 outbreak among its employees.

• 31 January – 18 March 2022 – FDA proceeds with an inspection of Sturgis plant despite the

COVID-19 outbreak given the fact pattern indicating a potential issue. FDA finds significant, 

fundamental sanitation, building, and equipment issues and takes multiple environmental samples.2

• 7 February 2022 – Seven of FDA’s environmental swabs suggest the potential presence of

Cronobacter, but require confirmatory testing.

• 9 February 2022 – FDA leadership informed of potential positive samples, defined as “Cannot Rule 

Out” (unconfirmed) taken during the inspection of Abbott Nutrition’s Sturgis plant.

• 10 February 2022 –Food Program Leadership meets, and FDA’s Coordinated Outbreak Response 

Network begins coordinating a response.

• 11 February 2022 – FDA notifies USDA’s WIC program of potential action that could impact the infant 

formula supply.

• 13 February 2022 – FDA sequences six confirmed samples of Cronobacter collected from Abbott 

Nutrition’s Sturgis facility environment during the recent inspection. Nineteen additional samples are

being sequenced.

• 14 February 2022 – An FDA intra-agency group, including experts and leadership from OFPR and 

CFSAN, begins discussions of food safety, regulatory, and supply chain issues related to the response.

FDA updates USDA WIC on the investigation status.

• 15 February 2022 – FDA recommends Abbott Nutrition voluntarily recall product. FDA receives

additional Cronobacter sample results, meets with USDA WIC on the investigation, potential for a

recall, and supply chain issues. Abbott Nutrition voluntarily ceases production. FDA seeks, and Abbott

Nutrition agrees to, exclude and hold specialty metabolic products given the critical access need and

Abbott Nutrition’s lack of a mitigation plan to produce these formulas at one of its other facilities. 

2 U.S. Food and Drug Administration, “Form 483: Inspectional Observations; Abbott Nutrition, Sturgis, Michigan Facility,” January 

31-March 18, 2022, available at https://www.fda.gov/media/157073/download?utm_medium=email&utm_source=govdelivery.

 2022
4 Timeline of infant formula related activities

• 16 February 2022 – FDA again recommends Abbott Nutrition voluntarily recall product. FDA, as a CoSector Risk Management Agency of the Food and Agriculture Sector, submits a report to U.S. 

government (USG) partners on the potential recall and supply chain impacts given the significant 

market share held by Abbott Nutrition, as well as the Sturgis facility being a critical producer of

specialty metabolic and amino acid formulas. FDA begins discussion with Abbott Nutrition on

additional testing for these held products and a strategy to release products to those in dire need. FDA 

meets with the American Academy of Pediatrics to make them aware of a significant upcoming action 

involving infant formula that will have ramifications for supply chains. We share that our 

communications would advise parents to consult with the child’s health care provider for advice, with

additional communications forthcoming from FDA.

• 17 February 2022 – Following a third recommendation by FDA that Abbott Nutrition voluntarily recall

product, FDA issues a consumer advisory warning consumers to avoid certain Abbott Nutrition

products as Abbott Nutrition voluntarily recalls product. FDA begins regular reports and coordination

with USG partners on supply chain. CDC notifies FDA of a fourth case that may be related. Daily 

situation reports begin for FDA staff and leadership working on the response. FDA requests from

IRI infant formula in-stock rates at the national level, which was not previously tracked by FDA. FDA 

requests that FMI, the Food Industry Association (FMI) ask retailers to limit sales to no more than five 

cans per shopper; FMI recommends the limit to retailers later that day.

• 18 February 2022 – FDA receives a fourth Cronobacter case report of a death potentially associated

with Abbott Nutrition product (Case Complaint #4). FDA contacts other infant formula manufacturers to 

discuss actions to address potential supply chain disruptions. The date of illness onset for this case 

was 4 January 2022. No clinical isolate is available, and product samples do not test positive for 

Cronobacter. FDA requests an independent expert conduct a batch review of held specialty metabolic 

product.

• 22 February 2022 – First infant formula data sets obtained by FDA from IRI.

• 24 February 2022 – Russia invades Ukraine. This leads to additional uncertainty in the infant formula 

supply chain as Ukraine is a major exporter of sunflower oil, an ingredient used in many infant formulas. 

Manufacturers begin to re-assess their supplies and make plans in consultation with FDA about 

possible substitutions.

• 28 February 2022 –Abbott Nutrition voluntarily expands its recall at FDA’s recommendation to cover

additional products associated with the fourth case complaint.

• Late February – early March 2022 – FDA meets with retailers and other infant formula manufacturers

throughout this period on actions to address infant formula supply chain and to seek supply chain

information. FDA continues regular coordination with manufacturers. FDA follows up on several

additional Cronobacter complaints but eventually determines them unrelated to Abbott Nutrition.

Actions ultimately result in significant increases in domestic production by late April and early May.

• 15 – 16 March 2022 – FDA inspection team returns to Sturgis facility to obtain additional records

related to complaints received. FDA receives FY 2022 additional funding to hire four additional infant

formula staff.

• 18 March 2022 – January 2022 inspection and related sampling activities conclude. Inspection is

closed, and FDA issues its inspection observations (FDA Form 483).3 Observations from inspection and 

FDA’s lack of confidence in Abbott Nutrition’s food safety culture inform FDA’s decision to negotiate a

consent decree with the goal of addressing these observations and safely resuming production at

Sturgis as soon as possible.

• 28 March 2022 – FDA’s FY 2023 budget request includes infant formula and medical foods supply

chain legislative proposal. 

3 U.S. Food and Drug Administration, “Form 483: Inspectional Observations; Abbott Nutrition, Sturgis, Michigan Facility,” January 

31-March 18, 2022, available at https://www.fda.gov/media/157073/download?utm_medium=email&utm_source=govdelivery.
Timeline of infant formula related activities 5

• 31 March 2022 – Abbott Nutrition provides FDA the independent batch review of specialty metabolic

product requested 18 February.

• 1 April 2022 – FDA transforms response activity to an Agency-wide Incident Management Group to

manage the response, including supply chain.

• 20 April 2022 – FDA communicates to Abbott Nutrition our decision not to object to release of

specialty metabolic product broadly after enhanced finished product testing, and not to object to 

release on case-by-case basis for urgent need. This was communicated to Abbott Nutrition again on

20 April and 28 April.

• 29 April 2022 – FDA issues an updated advisory to ensure consumers are aware of Abbott Nutrition’s

process to release metabolic formulas on a case-by-case basis, in consultation with a healthcare

provider, to those families who have no alternative supply.

• 16 May 2022 – FDA and Abbott Nutrition sign a proposed consent decree.

• 16 May 2022 – U.S. District Court for the Western District of Michigan enters the consent decree. FDA

issues enforcement discretion guidance to provide flexibilities to boost the supply of infant formula.

• 20 May 2022 – FDA issues its first enforcement discretion letter for a specialty infant formula product. 

FDA is evaluating additional requests for enforcement discretion. FDA is working with USG partners to

arrange air transport for amino acid and hypoallergenic hydrolyzed formulas to arrive in the United

States on 22 May 2022.