FDA WARNING_LETTER - Sterling Pharmaceutical Services LLC - February 18, 2022

On September 27, 2022, the FDA issued a Warning Letter to Sterling Pharmaceutical Services, LLC, following an inspection from February 7-18, 2022, at their Dupo, Illinois facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to investigate discrepancies (21 CFR 211.192):** The firm, a contract manufacturer of sterile ophthalmic drugs, failed to adequately investigate repeated microbiological contamination in ISO 5 aseptic processing areas, including a sterility failure for one lot. Their "Restricted Access Barrier Systems" (RABS) lacked fundamental design elements like glove ports, permitting excessive operator intervention. Investigations were deemed inadequate, failing to address persistent adverse trends or consider design flaws. 2. **Inadequate environmental monitoring (21 CFR 211.42(c)(10)(iv)):** The environmental monitoring (EM) program, including personnel monitoring, was insufficient, with observed failures to monitor non-viable particulates and limited personnel monitoring. 3. **Failure to prevent microbiological contamination (21 CFR 211.113(b)):** The firm lacked adequate procedures to prevent contamination. Investigators observed poor aseptic behaviors, undocumented interventions,