FDA WARNING_LETTER - RemedyRepack, Inc. - November 10, 2022

The FDA issued a Warning Letter to RemedyRepack, Inc. following an inspection from November 7-10, 2022, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Cleaning Procedures (21 CFR 211.67(b)):** The firm failed to establish adequate written procedures for equipment cleaning and maintenance. Quality control checks missed contaminated surfaces, visibly contaminated tablets/capsules were noted, and chemical testing for residue removal was lacking. Clean hold times were not supported by studies. The firm's response was deemed inadequate for not providing scientific evidence for interim cleaning, a comprehensive validation protocol, or an assessment of market impact. 2. **Insufficient Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate discrepancies, such as recurring broken tablets, treating them as isolated incidents without adequate root cause determination, CAPA, or assessment of all affected batches. The response was inadequate for not providing a comprehensive investigation or CAPA plans. 3. **Lack of Process Validation (21 CFR 211.100(a)):** The firm failed to validate drug packaging processes, lacking product-specific protocols and pre-approved acceptance criteria. Equipment qualification was also inadequate. The response was insufficient for not addressing risk assessment for marketed products or product quality impact. 4. **Inadequate Facility Design