
On May 6th 2025 the FDA announced the expanded use of unannounced inspections at foreign manufacturing facilities that produce food and medicines intended for American consumers and patients.

“For too long foreign companies have enjoyed a double standard – given advance notice before facility inspection, while American manufacturers are held to rigorous standards with no such warning. That ends today. This is a key step for the FDA as part of a broader strategy to get foreign inspection back on track” said FDA Commissioner Martin A Makary M.D., M.P.H.
The FDA news release announced that “In addition, the FDA will evaluate its policies and practises for improvements to the foreign inspection program to ensure that FDA is the gold standard for regulatory oversight. These changes will include clarifying policies for FDA investigators to refuse travel accommodations from regulated industry including lodging and transport to maintain the integrity of the oversight process.”
According to the FDA, “while US manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process.” Despite this advanced warning to foreign firms, the FDA states that they still found serious deficiencies twice as often with foreign than domestic firms.
Following an inspection, the agency evaluates the inspection findings to determine if the facility is in compliance with applicable laws and regulations.
The three classifications are :
- No action needed
- Voluntary actions indicated
- Official action indicated
“this expanded approach marks a new era in FDA enforcement – stronger, smarter and unapologetically in support of the public health and safety of Americans.” – FDA.
For an Irish FBO it is essential to understand the FDA approach to auditing. Knowledge of the CFRs is a must. Each subpart within the CFRs is logical and strategic. Subpart A – Knowledge and Context, Subpart B – GMP/ Environment, Subpart C – Process and Product. They have an overwhelming focus on the product you produce and the environment where it is made. Their single-minded focus on the “reasonably foreseeable hazard” that can adversely affect the health of the American is both logical and refreshing. Food Safety Culture is a much utilised phrase at the moment but it can be distilled down to “how one thinks and behaves”. The FDA want to assess how you think, is it aligned with the way they think and let’s go down your factory floor to assess your behaviours. The zoning and sanitation of your premises is paramount.
“the zoning of your premises is essential to the harmony of your process and manufacture of your product for the well-being of the American.”
“the zoning (GMP – Subpart B) of your premises is essential for the harmony of your process (Subpart C) and manufacture of the product (micro criteria) to ensure the well-being of the Americans.”