Findings
1Quality 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). You manufacture an over-the counter (OTC) drug product, a topical psoriasis cream, for the U.S market. Your quality unit (QU) failed to ensure that all CGMP records were retained and available for review. Our investigators discovered a garbage…
2Laboratory and QC controls
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)). You failed to ensure components and drug products are adequately monitored for microbiological…
3Process validation
Your firm failed to establish adequate written procedures for production and process control designed to assure that drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and to follow all of your written production and process control procedures (21 CFR 211.100(a) and 211.100(b)). You failed to demonstrate adequate validation of your manufacturing process. You were unable to demonstrate that your (b)(4)…
About this record
Extracted automatically from the document US FDA published on 2026-07-21. 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.
