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# CGMP Issues Found in PMS4PMS Inspection
- URL: https://www.fdaweb.com/cgmp-issues-found-in-pms4pms-inspection/
- Published: 2025-04-15T12:00:00.000Z
- Updated: 2026-09-14T15:09:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159006

An 11/4-11/8/2024 FDA inspection at the PMS4PMS drug manufacturing facility in Clarence, NY, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/7 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pms4pms-llc-700180-04072025?ref=fdaweb.com) says the specific CGMP violations were:

- failure to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release;
- failure to assure that the drug product bore an expiration date that was supported by appropriate stability testing; and
- failure of the firm’s quality control unit to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter says the firm’s Comfort Menstrual Cramp Relief Cream is an illegally marketed unapproved new drug that is misbranded because it does not comply with the requirements for marketing a nonprescription drug product.

FDA acknowledges that the company has committed to cease production of its menstrual cramp drug at this facility and asks it to indicate whether it intends to resume production. It recommends that if PMS4PMS intends to resume drug production, it engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

The firm was told to correct the violations promptly and 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.