FDA WARNING_LETTER - PMS4PMS - November 08, 2024

The FDA inspected PMS4PMS, LLC's drug manufacturing facility from November 4-8, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug product adulterated. The "Comforté® Menstrual Cramp RELIEF CREAM" product was also cited as an unapproved new drug and misbranded.

Key violations include: 1. **Lack of Laboratory Testing (21 CFR 211.165(a)):** Failure to perform identity and strength testing of the active ingredient for each batch prior to release, including products still within expiry. 2. **Inadequate Stability Testing (21 CFR 211.137(a)):** Failure to establish and maintain a stability testing program to support the labeled 5-year expiry period. 3. **Deficient Quality Control Unit (21 CFR 211.22):** The quality unit failed to ensure drug products complied with CGMP and met specifications for identity, strength, quality, and purity.

The company's November 22, 2024, response to the FDA Form 483 was deemed inadequate due to insufficient supportive documentation and evidence of corrective actions. The FDA recommends engaging a qualified CGMP consultant to evaluate operations and assist with compliance if the firm intends to resume drug manufacturing.

The "Comforté® Menstrual Cramp RELIEF CREAM" is an un