Rite-Kem Incorporated – FDA Warning Letter, Sep 12, 2024

The FDA inspected Rite-Kem Incorporated, a drug manufacturing facility, from September 9-12, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to test finished drug products:** The firm did not adequately test batches of OTC drug products (hand sanitizers, antimicrobial hand soap, antimicrobial towels) for identity and strength of active ingredients (e.g., ethanol, benzalkonium chloride, chloroxylenol) or perform microbiological testing prior to release. Their response, proposing a 9-month implementation, was deemed inadequate for lacking sufficient detail, justification, and a retrospective review of released products. 2. **Failure to test components and validate supplier analyses:** The firm failed to perform adequate identity testing for each component lot, including high-risk components like glycerin (for DEG/EG contamination) and ethanol (for methanol contamination), and relied on supplier Certificates of Analysis without validation. Their 9-month implementation plan for component testing and supplier qualification was also deemed inadequate, lacking detail and retrospective testing of reserve samples. 3. **Inadequate Quality Control Unit oversight:** The Quality Unit failed to ensure drug products complied with CGMP and met specifications, indicating inadequate quality systems.

Rite-Kem has temporarily suspended drug production and is advised to engage a qualified CGMP consultant to evaluate operations, perform a comprehensive six-system audit, and