Sterling Pharmaceutical Services, LLC — FDA Warning Letter Findings

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). Your firm had not established adequate procedures designed to prevent microbiological contamination risks in your facility. For example, your firm did not routinely document interventions performed by aseptic…

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). Your firm is a contract manufacturer of sterile over-the-counter and homeopathic ophthalmic drug products utilizing aseptic processing. You identified your aseptic processing lines as Restricted Access Barrier Systems (RABS). However, your systems…

Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)). Your EM program (including personnel monitoring) was inadequate for classified areas used for the production of sterile ophthalmic drug products. We observed instances during production of two lots of sterile eye drops in which your firm failed to ensure adequate monitoring of non-viable particulates (NVP). Furthermore, personnel…