Par Health USA, LLC & Endo USA, Inc. — FDA Warning Letter Findings

Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). Your visual inspection program was inadequate to ensure your sterile injectable drug products were…

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)). Inadequate Process Simulation Your media fills failed to accurately simulate aseptic manufacturing operations. Your data reported maximum aseptic intervention counts per batch of over (b)(4) for line (b)(4) and…

Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)). Inadequate Design of Facility and Equipment Your firm is a contract manufacturer of sterile injectable drug products produced primarily through aseptic processing including, but not limited to, products for (b)(4) use…