Findings
1Material and supplier control
Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). You failed to perform adequate identity testing of each component lot used in the manufacture of your drug products, such as (b)(4) . Identity testing of high-risk drug components (e.g., (b)(4) )…
2Deviation, CAPA, and investigation
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) did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure the following: Adequate investigations into out-of-specification (OOS) results that include scientific…
3Equipment and facility
Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. You also failed to establish written procedures for cleaning and maintenance of equipment (21 CFR 211.67(a) and 211.67(b)). You…
About this record
Extracted automatically from the document US FDA published on 2026-04-14. 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.
