November 21, 2024
The U.S. Food and Drug Administration (FDA) has been ramping up on-site inspections of regulated manufacturers’ facilities to identify and address quality system failures.
With a higher number of inspections comes increased manufacturer risk for Form 483 observations and the subsequent issuance of Warning Letters.
Your quality team needs to prepare for the FDA’s increased scrutiny of your operations to address issues noted in Form 483 to avoid a Warning Letter.
Current and Emerging FDA Inspection Trends
Across regulated industries, FDA has announced several significant changes and proposed new legislation signaling a renewed focus on inspections and enforcement of regulation compliance.
It is clear the agency has bounced back from its lag in inspections during the pandemic and is poised to make up for lost time.
FDA 2025 budget and legislative priorities related to inspections
Within its fiscal year (FY) 2025 proposed budget of $7.2 billion, the FDA has identified funding opportunities aimed at enhancing inspections domestically and globally. These include:
- Hiring additional investigators to fulfill inspectional needs associated with increased supply-chain disruptions and consequent human food and medical product shortages.
- Funding for the agency’s Human Foods Program to invest in the necessary tools and processes to modernize its capacity to prevent or mitigate foodborne illness outbreaks by strengthening root-cause investigations.
- Funding to support the expansion of the agency’s foreign-office footprint, expanding agency resources to facilitate timely inspections of foreign facilities in specific countries.
The FDA’s FY 2025 budget also includes proposed legislation to expand the agency’s inspection authority in the following ways:
- Expanding the agency’s ability to request records or other information in advance of or in lieu of inspections to explicitly include food, tobacco product, and cosmetic establishments.
- Requiring remote regulatory assessments (e.g., livestreaming video of operations, teleconferences, and screen sharing) so FDA may interact virtually with an establishment and assess its compliance with applicable laws and regulations.
- Conducting certain oversight activities prior to arriving for or instead of an inspection; thereby improving the efficiency of FDA resources and reducing the agency’s on-site inspection time.
- Providing the agency a formal, designated opportunity to use a risk-based approach to determine if an inspection of manufacturing facilities for non-application drugs is necessary before the drugs are distributed.
- Requiring the industry to report all product positive test results for relevant pathogens in critical foods and conduct more frequent environmental monitoring in their facilities to identify the presence of relevant pathogens on surfaces from which the risk of critical food contamination is the greatest. Additionally, the results of such testing for FDA inspection should be maintained, either in person or remotely.
New Office of Inspections and Investigations (OII)
The FDA announced on June 3, 2024, that it would retitle the Office of Regulatory Affairs (ORA) to the Office of Inspections and Investigations (OII) “and establish new inspection and investigation offices to focus on inspections, investigations and imports as its core mission.”
While the FDA announced the change as part of its unified Human Foods Program, the agency noted how restructuring the OII “extends beyond foods and has an impact on how the FDA oversees all FDA-regulated products.”
New inspection process to align with QMSR
On January 31, 2024, the FDA issued a final rule amending the device Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems (QMS) for medical devices used by many other regulatory authorities around the world.
Under the rule, the FDA will develop a new inspection process to align with the requirements of the new Quality Management System Regulation (QMSR). The process will be developed for implementation when the rule takes effect on February 2, 2026.
Since quality management professionals in highly regulated industries – drugs, devices, food – bear a tremendous burden in ensuring compliance throughout their companies’ product lifecycles – from raw material and components to post-market surveillance, having automated quality management system software (QMS) will help manage compliance tracking and provide necessary insights to identify product issues before they arise.
With more FDA inspections expected on the horizon, now is the time for drug, medical device and food manufacturers to examine their quality management systems to not only ensure they comply with FDA regulations related to their industries but also enable them to efficiently and effectively issue an adequate response when presented with a Form 483.
About the Author
Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.
