The Department of Health and Human Services’ Office of Inspector General (OIG) discovered the FDA waited 15 months to respond to a complaint about the conditions at an Abbott Nutrition facility.
Those conditions led to a nationwide formula shortage in 2022.
The whistleblower claimed employees cut corners:
For instance, according to the complaint, the employee reported observing events that were understated or inaccurately described “to limit or avoid oversight” and then “failing to maintain accurate maintenance records.”After several samples of a batch of infant formula were found to contain microorganisms, or “micros,” the whistleblower claims that the plant performed a time code removal, in which formula produced around the same time as the contaminated samples was discarded, but formula produced outside of those time codes was released to be sold without additional testing to make sure it was safe for consumption.In 2020, the complaint says, product wasn’t recalled from the market even after management became aware of a problem with the integrity of the packaging, an issue that the whistleblower said should have caused the manufacturer to take the product off shelves and conduct more testing.
The tainted formula caused the death of two infants, and several landed in the hospital.
The OIG also found that the FDA doesn’t have policies to identify problems with the formula.
FDA had inadequate policies and procedures or lacked policies and procedures to identify risks to infant formula and respond effectively through its complaint, inspection, and recall processes. For example, FDA had not developed an organizational structure or assigned responsibilities to handle whistleblower complaints in an efficient and effective manner and took more than 15 months to address a February 2021 Abbott facility whistleblower complaint. In addition, FDA did not escalate an October 2021 whistleblower complaint to senior leadership, resulting in a nearly 4-month delay before senior leadership was aware of the complaint. We also found that FDA did not have policies and procedures to establish timeframes for the initiation of mission-critical inspections, which contributed to one inspection being initiated 102 days after a whistleblower complaint was received. Further, FDA did not have sufficient policies and procedures on how to initiate an infant formula recall under its FDA-required recall authority.
The FDA received two complaints from one whistleblower. A second whistleblower sent one in April 2022 with different information.
The first whistleblower sent the complaint to the Department of Labor, which then sent it to the FDA’s whistleblower inbox.
Despite having a dedicated inbox, the OIG said the “FDA did not have adequate policies and procedures for identifying and investigating whistleblower complaints received” in the box.
This is insanity:
We also found that, with regard to whistleblower complaints, FDA did not develop an organizational structure or assign responsibilities to enable the organization to operate in an efficient and effective manner. According to FDA officials, in February 2021, FDA did not have a permanent NCCC [National Consumer Complaint Coordinator], and the NCCC position was covered by other individuals. When there is not a permanent NCCC, FDA assigns the NCCC’s duties to other individuals to maintain the continuity of operations. The NCCC plays an important role in: (1) identifying and accounting for whistleblower complaints by monitoring email inboxes for whistleblower complaints, (2) assigning whistleblower complaints to the appropriate district office or center, and (3) recording receipt and followup activities for all whistleblower complaints. FDA provided documentation showing that the NCCC position was vacant from January 5, 2020, through July 31, 2021, and was filled on August 1, 2021. The individuals covering the NCCC’s duties in February 2021 had other responsibilities and did not identify the February 2021 whistleblower complaint when DOL sent it. FDA stated that an individual covering the NCCC’s responsibilities inadvertently archived the February 2021 whistleblower complaint and did not forward it to ORA for investigation. FDA identified the February 2021 whistleblower complaint and forwarded the complaint to ORA [Office of Regulatory Affairs] in June 2022 following a search prompted by a press inquiry about the whistleblower complaint.
Before July 26, 2021, the FDA had no instructions or procedures to send whistleblower complaints to senior leadership.
The agency dropped the “unwritten policy” and said it would treat the complaints like consumer complaints.
Guys, it gets worse.
The whistleblower sent hard copies of the complaints directly to seven FDA employees in October 2021.
Yes, SEVEN employees.
The whistleblower also sent the hardcopies to “certain ORA district directors, ORA district staff, and the FDA Medical Director for Infant Formula and Medical Foods.”
Yes, the whistleblower sent hard copies to the FDA Medical Director for Infant Formula and Medical Foods.
I’m fuming.
Senior leadership blamed the lack of mailroom staff due to COVID.
Um, that doesn’t excuse the lack of action on the emails.
A proper investigation of the facility showed “unsanitary conditions, a leaky roof, lax safety practices and multiple strains of a bacteria that can be deadly to infants.”
The plant shut down for months, causing a national shortage.
“Had [the] FDA initiated the Abbott facility inspection sooner, [the] FDA may have identified the issues at the Abbott facility and recommended that Abbott recall products sooner,” said the report.
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