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# CGMP Violations Seen in Port Jervis Records Review
- URL: https://www.fdaweb.com/cgmp-violations-seen-in-port-jervis-records-review/
- Published: 2026-06-11T12:00:00.000Z
- Updated: 2026-09-14T13:41:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161296

An FDA review of records it requested 9/ 8/2025 from Port Jervis Laboratories, a manufacturer of over-the-counter drugs in Port Jervis, NY, documented violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/2 [Notice of Violation](https://www.fda.gov/media/193007/download?attachment&ref=fdaweb.com) says the specific violations were:

- failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality; and
- failure of the firm’s quality control unit to exercise its responsibility to ensure drug products are manufactured in compliance with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter acknowledges the company’s statement that it no longer manufactures or distributes drug products containing talc, and reminds Port Jervis of its responsibility for the quality of drugs it produces as a contract manufacturer, regardless of any agreement in place with the product owners.

Port Jervis was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.