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 firm failed to demonstrate that your microbiological test methods were appropriate to assure…
2Process 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)). Inadequate Process Validation You manufacture over-the-counter (OTC) drug products, such as topical creams, including sunscreens. You failed to demonstrate you have adequately validated the manufacturing processes…
3Deviation, CAPA, and investigation
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 failed to conduct adequate investigations into out-of-specification (OOS) results. For example, an OOS for bulk base batch (b)(4) , documented low potency for one of the active pharmaceutical ingredients (APIs). The corrective action was to…
About this record
Extracted automatically from the document US FDA published on 2025-06-03. 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.
