FDA WARNING_LETTER - Rechon Life Science AB - September 06, 2024

The FDA inspected Rechon Life Sciences AB in Limhamn, Sweden, from August 26 to September 6, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Failure to prevent microbiological contamination (21 CFR 211.113(b)):** Operators were observed touching critical aseptic processing line surfaces with gloved hands, a practice permitted by SOP-0870-3.0 and demonstrated in smoke studies. The firm's response was inadequate, as the revised procedure still allows for such contact, conflicting with CGMP guidance. 2. **Inadequate investigations (21 CFR 211.192):** * **Environmental Monitoring (EM) excursions:** Persistent recovery of objectionable microorganisms (gram-negative organisms, spore formers) in ISO 5 and 7 areas and on personnel since 2022, a repeat deficiency. Investigations lacked holistic evaluation of contamination sources. * **Out-of-Specification (OOS) results:** OOS investigations lacked scientific rationale for root cause determinations, with original results invalidated without clear laboratory error or manufacturing assessment. The revised OOS procedure remains inadequate, not requiring manufacturing investigations prior to data invalidation unless an obvious lab error. 3. **Inadequate cleaning and disinfection system (21 CFR 211.