FDA ready for resumption of domestic inspections after slowdown

On July 10, 2020, the U.S. Food and Drug Administration (FDA) announced they plan to resume prioritized domestic inspections of FDA-regulated facilities and other associated activities.  This is following their postponement of on-site inspections in March of this year due to the COVID-19 pandemic. Now, with the agency under intense pressure to crack down on producers who sped up production to meet the demand during the last few months, companies must be prepared.1

The White House Guidelines for Opening Up America Again2 will provide a roadmap for optimizing operations and new work arrangements. Also, the regions of the U.S. that will be on the receiving end of these inspections are those that the agency’s rating system demonstrates are the safest for conducting prioritized inspections. To ensure the safety of the investigator and the firm’s employees, the inspections will be pre-announced to FDA-regulated businesses for the foreseeable future.1

The following are some items to consider regarding the inspections:

1)     Don’t expect to use COVID-19 as your excuse for absence. The agency will notify the company in advance and the inspector will anticipate the appropriate staff is available for the inspection.

2)     Top priority list visited first. Companies with repeated warnings about quality or safety issues will be on the top of the FDA list.

3)   High-demand, high-risk product categories are top focus. Products that have been in high demand during recent months, such as hand sanitizer, medical equipment and medicine, will be a top priority category.

4)     Supply chains will be analyzed. If overseas manufacturers/suppliers are used, potential quality investigations will be necessary since the FDA is unable to conduct inspections overseas

Overseas Facility Inspection Status

FDA inspections of overseas’ facilities have not resumed. Some groups have requested that the FDA consider virtual inspections for new facilities, facilities that plan to produce a new class of drugs, and facilities that have addressed a recent inspection failure. Virtual inspections could also provide the immediate need for overseas pharmaceutical facility inspections since, as of May 2020, 74 percent of facilities manufacturing active pharmaceutical ingredients (APIs) and 54 percent of the facilities producing finished dosage forms (FDFs) of human drugs for the U.S. market were located outside the U.S. (See Figures 1 and 2). 3  It is also estimated that 97 percent of antibiotics prescribed in the U.S. come from China.4

Resources:

1.     Stephen M. Hahn, M.D., “Coronavirus (COVID-19) Update: FDA Prepares for Resumption of Domestic Inspections with New Risk Assessment System”, FDA, July 10, 2020
2.    “Guidelines: Opening Up America Again”, Whitehouse & CDC
3.     Judith A. McMeekin, Pharm.D., Mark Abdoo, and Douglas Throckmorton, M.D., “COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process”, FDA Congressional Testimony, June 2, 2020
4.     Tanzhong Huang, “U.S. Dependence on Pharmaceutical Products From China”, Council on Foreign Relations, August 14, 2019

Disclaimer: Berkley Global Product Recall is pleased to share this material with its customers. Please note, however, that nothing in this document should be construed as legal advice or the provision of professional consulting services. This material is for general informational purposes only, and while reasonable care has been utilized in compiling this information, no warranty or representation is made as to accuracy or completeness.