FDA WARNING_LETTER - Kingston Pharma LLC - December 10, 2018

The FDA inspected Kingston Pharma LLC (Massena, NY) from November 13 to December 10, 2018, identifying significant CGMP violations and misbranded drug products. The firm's drug products are deemed adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Inadequate Quality Control Unit Procedures (21 CFR 211.22(d)):** The Quality Unit (QU) released drug batches before reviewing all test results and failed to document line clearance/filling activities. There was no audit trail review procedure, and QU personnel couldn't show HPLC audit trails. The firm's response was inadequate as it didn't include a retrospective review of all released batches for active ingredient identity and strength. 2. **Lack of Process Validation (21 CFR 211.100(a)):** The firm failed to validate manufacturing processes, missing key parameters like blending speeds and hold times, and did not qualify equipment. The response was inadequate for not specifying additional controls during validation and failing to address the impact on distributed products. 3. **Inadequate Stability Testing Program (21 CFR 211.166(a)):** The firm lacked sufficient stability data for RESFRIOLITO Children’s Cold, Cough & Sore Throat to support its two-year expiration date. The response was