BRS Analytical Services, LLC — FDA Warning Letter Findings

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22) Your quality unit (QU) failed to maintain adequate CGMP oversight and allowed the distribution of sterile (b)(4) drug products manufactured under unacceptable conditions, which included poorly designed facilities, an unsuitable aseptic…

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)). Poor Aseptic Behavior We observed poor practices in ISO 5 areas during your (b)(4) intensive aseptic processing of sterile (b)(4) drug products, including but not limited to: • Operators blocked unidirectional…

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. Your firm also failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and…