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# FDA Domestic Inspections Fall, Foreign Rise: Study
- URL: https://www.fdaweb.com/fda-domestic-inspections-fall-foreign-rise-study/
- Published: 2025-03-07T12:00:00.000Z
- Updated: 2026-09-14T14:54:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158785

Most of FDA’s drug inspection-based Warning Letters issued in fiscal year 2024 went to domestic firms, although the percentage of international firms being inspected ticked upward, according to Eliquent Life Sciences’ (formerly consulting firm Greenleaf Health) officials **Liz Oestreich**, **Kalah Auchincloss**, and **Erin Hartmann**. Writing in an [online guest column](https://www.bioprocessonline.com/doc/trends-in-fda-fy-2024-inspection-based-warning-letters-0001?ref=fdaweb.com), the authors note that while domestic facilities continued to receive the most attention, the percentage of domestic inspections compared to international inspections dropped significantly. “In FY23, roughly 83% of inspection-based warning letters were issued to domestic firms (78 of 94),” they wrote. “In FY24, roughly 61% of inspection-based Warning Letters were issued to domestic firms. Specifically, 68 of 111 letters went to domestic firms whereas 43 went to international firms or facilities located outside the U.S.”

The authors say the agency remains focused on component testing, “as various contaminants have permeated the OTC drug space, specifically in hand sanitizers and other topical products.” The top five citations in 2024 Warning Letters were:

- Failing to establish adequate written procedures for production and process controls
- Failing to test identity of drug product components
- Failing to verify validity of analysis reports received from suppliers of drug components
- Quality control unit failing to ensure manufacturing adheres to GMPs
- Failing to thoroughly investigate unexplained discrepancies or the failure of a batch

The authors also note that Warning Letters have become “more instructive on a point-to-point basis. In addition to clearly articulating why a 483-response failed to address an observation, the FDA is now offering equally instructive guidance on resolution of the issues. The FDA frequently requests specific commitments for each observation with detailed deliverables and timelines.

“For example,” they continue, “in response to data integrity lapses cited in the Warning Letter to Optikem International, the FDA requests a comprehensive investigation into the extent of the inaccuracies in data records and reporting. The FDA goes on to state the investigation should include (among other things) a ‘comprehensive retrospective evaluation of the nature of the testing and manufacturing data integrity deficiencies,’ including ‘\[a\] current risk assessment of the potential effects of the observed failures on the quality of your drugs. \[The\] assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.’ The letter continues to request ‘a commitment to have a qualified consultant conduct extensive annual audits, for at least two years, to assist in evaluating CAPA effectiveness after \[the firm has\] executed \[its\] data integrity remediation protocol.’”

Additionally, they note that some letters have asked for comprehensive risk assessments on certain areas, including a list of elements to be considered in the assessment. “Within these risk assessments, the FDA is specifically directing companies to perform a comprehensive assessment of operations, procedures, personnel, and/or perform audits of systems to identify additional issues,” the authors say. “To ensure understanding, the FDA provides Web site links to relevant guidance documents. The FDA’s detailed instruction on action items needed for remediation are written as if they could be copied and pasted into a contract with a consulting firm.”