Findings
1Quality unit oversight
Your firm failed to establish 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, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)). Your firm failed to adequately qualify the equipment and validate the processes used to manufacture your drug products…
2Quality unit oversight
Your firm failed to establish an adequate quality control unit, and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)). Your Quality Unit (QU) lacked control over your topical over-the-counter drug manufacturing operations and failed to ensure that you had adequate procedures. For example, your QU failed to: Evaluate product quality before batch release. Your firm obtained…
3Documentation and records
Your firm failed to prepare batch production and control records that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product (21 CFR 211.188(b)). Your batch production and control records lack adequate manufacturing details including, but not limited to, the following: weights of charged components, mixing times, mixing speeds, measured temperatures, hold times…
About this record
Extracted automatically from the document US FDA published on 2021-03-22. 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.
