Findings
1Laboratory and QC controls
Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, and for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary (21 CFR 211.165(a) and (b)) Your response to our request for records and other information under…
2Process validation
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 (21 CFR 211.100(a)). Based on the information you provided, you did not demonstrate that your manufacturing processes are reproducible and controlled to yield a product of uniform character and quality. For example, we asked you to provide a…
3Material and supplier control
Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)). Based on the records and information you provided, you did not demonstrate adequate testing of the identity of incoming components used in the manufacture of your drug products. Specifically, your response stated that raw material identity testing for each lot of each component is “Not Applicable,” testing of ethanol or isopropyl alcohol and…
About this record
Extracted automatically from the document US FDA published on 2023-03-14. 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.
