Findings
1Cleaning validation
Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). Your cleaning procedures lack sufficient detail to ensure repeatability between operators. We observed cleaning deficiencies and variability between operators, including wiping technique, using the same cleaning cloths for multiple areas, and failure to clean on top of the overhead light casings of the filling line. Further, the disinfection…
2Aseptic processing and sterility assurance
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)). Equipment as a Route of Contamination The design of the aseptic processing line used to manufacture over-the-counter (b)(4) drug products was inadequate. Line (b)(4) is a traditional filling line consisting of an ISO 5 area…
3Process validation
Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). Visual Inspection Your post-fill visual inspection of aseptically filled drug products was insufficient to identify defects which may be present. For example, bottles were only inspected against a (b)(4) background…
4Quality unit oversight
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). The QU failed to maintain adequate CGMP oversight. For example: Lack of Written Procedures (211.100) Numerous written procedures were either missing or lacked sufficient detail to ensure consistent repeatability between operators. For example…
5Aseptic processing and sterility assurance
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 Smoke Studies Smoke studies showed a lack of unidirectional airflow in your ISO 5 aseptic processing operation. Multiple instances of turbulent airflow in critical areas of filling line (b)(4) were…
About this record
Extracted automatically from the document US FDA published on 2025-07-15. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
