As reported yesterday, Abbott Nutrition has entered into a Consent Decree of Permanent Injunction that spells out the conditions under which the company will be permitted to recommence and continue powdered infant formula production at its Sturgis, Michigan, plant.
Despite the company’s protestations of innocence regarding the outbreak of four cases of Cronobacter sakazakii illnesses–including two deaths–in infants who consumed Abbott’s products, the formal Complaint filed by the US Justice Department sets out very clearly the extent of Abbott’s culpability.
After summarizing the relevant statutes, regulations and rules, the Complaint lists the following supporting evidence, found during the inspections carried out by US Food and Drug Administration (FDA) investigators in September 2021 and January-February 2022.
- FDA lab analysis found C. sakazakii on several surfaces in the production area, including the cover of a hopper that feeds scoops directly into infant formula containers. The sample was collected at the time a batch of formula was being packaged, and the scoops come into direct contact with product.
- Abbott’s own environmental samples confirmed the presence of Cronobacter spp. on surfaces in the powdered infant formula production area between September 25, 2019, and February 20, 2022. The company did not perform the necessary test to determine whether or not the bacteria were Cronobacter sakazakii.
- On January 31, 2022, FDA investigators noted the presence of pooled water on several levels of a multi-story spray dryer tower while the spray dryer was being used to produce a batch of powdered infant formula.
- Abbott’s own records documented a total of 310 “water events” (leaks and condensation) between January 1, 2020, and February 1, 2022, in dry-production areas for powdered infant formula (e.g. during spray-drying and/or container-filling operations). Several of those leaks are described in the company’s records as necessitating repairs to a roof.
- Abbott had never validated the dry-out step for their spray dryers to ensure that the interiors of the dryers are completely dry following cleaning.
- Abbott’s own records documented a history of internal deterioration of the spray dryers dating back to September 2018, including (but not limited to) pits and cracks inside the dryers’ main chambers.
- Plant personnel working in the infant formula production area did not always wear necessary protective apparel.
- The company failed to conduct an adequate investigation into the validity of a complaint that showed a possible health hazard existed, and failed to test any retained samples of the suspect production lot for microbiological contamination.
- At the completion of the September 2021 inspection, the FDA issued an FDA-483 form, listing several deficiencies. Although Abbott promised to take corrective action, the company did not implement sustained corrections or demonstrate ongoing compliance with statutory requirements.
On behalf of the FDA, the US Department of Justice has petitioned the Court to issue a permanent injunction requiring Abbott to “… cease manufacturing, processing, preparing, packing, labeling, holding, and/or distributing any article of food unless and until Defendants bring their manufacturing, processing, preparing, packing, labeling, holding, and distribution operations into compliance with the Act and its implementing regulations to the satisfaction of FDA.”
The request also includes authorization for FDA to inspect the company’s “… place(s) of business and all records relating to the receipt, manufacture, processing, preparing, packing, labeling, holding, and distribution of any article of food to ensure continuing compliance with the terms of the injunction, and that Defendants bear the costs of such inspections, including testing and sampling …” and to award costs to the government, including the cost of the investigation to date.
A short leash
The conditions stipulated in the Consent Decree under which Abbott Nutrition will be allowed to resume and maintain production will keep the company on a very short leash.
Abbott will be required to retain an independent expert or experts to evaluate all of the facilities and processes at the Sturgis, Michigan, location, and conduct an inspection to determine what will be necessary to bring the operation into compliance with FDA regulations. The company will be required to notify FDA of the identity and qualifications of the expert within two days after retaining him or her.
Abbott will need to verify the dry-out procedures and validate its method of testing for moisture in production equipment and processing environments.
A pre-production cleaning, sanitizing and dry-out followed by environmental testing for pathogens will be required.
Before starting production, Abbott will be required to provide FDA with a report from the expert that documents completion of all of the verification and validation activities and the pre-production review.
Once production has started, a qualified individual within Abbott’s quality unit will be required to review the batch record, product test results and environmental monitoring for every production lot prior to distribution of the lot. The responsible individual must certify in writing to FDA that each lot meets all specifications.
The consent decree also specifies the testing that must be conducted, and that production be halted and FDA be notified immediately in the event that any in-process or finished product test detects Cronobacter and/or Salmonella. Production will only resume after Abbott receives written permission from FDA.
Abbott must maintain a record of all sales and distribution of its products and make those records available to FDA immediately upon request.
Additional details include specifics as to the required environmental monitoring, training of personnel, preparation and submission to FDA of a plan for building and/or equipment repair, hiring of an auditor to conduct audit inspections of the production facility, methods and processes.
Under the provisions of the decree, in the event the FDA determines that Abbott has not lived up to its agreement, the agency has the authority to order the company to cease manufacturing, and to take whatever other corrective actions the agency deems necessary for protection of public health.
In his blog post this morning, Bill Marler warns that criminal sanctions may be in the offing.
Let’s hope the FDA and the US Department of Justice don’t consider Abbott Nutrition to be “too big to nail.”
Learn more about Cronobacter sakazakii and other foodborne disease outbreaks in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, now available in digital, print and audiobook editions.