FDA to limit domestic inspections to “mission critical” cases; pre-announce the majority of such inspections; waive certain FSMA onsite audit requirements

AHPA Alerts

AHPA Alerts

AHPA keeps members and the industry informed of recent news and developments that impact the trade through email alerts. Subscribe to news as it happens or a weekly summary of all alerts.

Subscribe >>

View recent alerts:

Subscribe to AHPA Updates to stay informed about the latest AHPA news and resources.

Recent News

FDA to limit domestic inspections to “mission critical” cases; pre-announce the majority of such inspections; waive certain FSMA onsite audit requirements

Much of the teleconference was focused on the Agency’s online resources, such as its FAQ page, which was recently updated

Published: Thursday, March 19, 2020

Yesterday, the U.S. Food and Drug Administration (FDA) convened a teleconference meeting (FDA Briefing for Foods Stakeholders on Coronavirus Disease 2019 (COVID-19)), which was attended by AHPA president Michael McGuffin and by representatives of AHPA’s general counsel, Kleinfeld, Kaplan & Becker, LLP. FDA also issued a statement entitled “Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections.” The call included presentations by Frank Yiannas, Deputy Commissioner, Office of Food Policy and Response; Michael Rogers, Assistant Commissioner for Human and Animal Food Operations, Office of Regulatory Affairs; and Susan Mayne, Director, Center for Food Safety and Applied Nutrition. The purpose of the call was described as to address food safety in regard to the COVID-19 pandemic. The later-issued statement highlighted several points raised during the call.

Much of the call was focused on the Agency’s online resources, such as its FAQ page, which was updated on Tuesday. Key messages also included that there is no current food shortage even as supply needs to catch up with current high demands; that FDA remains committed to the safety of its own employees as well as food sector employees; and that, as also stated on its website, there is currently no evidence of food or food packaging being associated with transmission of COVID-19. With regard to this last point, FDA does not anticipate that food manufacturers will need to cease distribution of or recall foods in the event that an employee tests positive for COVID-19.

The speakers also called attention to guidance issued Tuesday to state the current intent of FDA, in certain circumstances related to the impact of the coronavirus outbreak (COVID-19), not to enforce requirements in three food regulations to conduct onsite audits of food suppliers if other supplier verification methods are used instead. The three regulations are identified as 21 CFR Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food); 21 CFR Part 507 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals); and 21 CFR Part 1 Subpart L (Foreign Supplier Verification Programs for Importers of Food for Humans and Animals). The announcement of the issuance of this guidance is here; the guidance here.

Perhaps the most newsworthy detail presented during the call and in the statement is that FDA will, at least for the short term:

  • Postpone routine domestic facility inspections;
  • Focus instead on only “mission critical” domestic inspections; and
  • In the majority of such cases, pre-announce and schedule these “mission critical” inspections.

FDA indicated that “mission critical” domestic inspections would include, for example, those related to a recall or a foodborne illness outbreak.

Note that FDA’s temporary approach to pre-announcing and scheduling the majority of these “mission critical” domestic inspections deviates from the Agency’s usual practice of arriving at food facilities unannounced during normal business hours. The Agency spokespersons clarified that this usual practice would still be utilized rarely but as needed during this period.

Note also that, earlier this month, FDA announced the postponement of most foreign facility inspections through April and that the Agency would consider conducting inspections outside the United States deemed “mission critical” on a case-by-case basis as this outbreak continues to unfold.

A recording of the teleconference is available to download.

Print

2020 Annual Fund Sponsors

   

AHPA appreciates the support of its sponsors, but does not endorse, recommend, or provide a warranty for any sponsor company, its products or services. AHPA has no responsibility for any transaction entered into with any of these companies.