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 (21 CFR 211.165(a)). Your firm manufactures an over-the-counter (OTC) drug product, (b)(4) Patch containing (b)(4) . Your response to our request for records and other information under section 704(a)(4) indicates that you…
2Cleaning validation
Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). Based on the information you provided in response to our request for cleaning procedures for cleaning equipment for U.S. product lines, you have not conducted cleaning validation studies. For example, in response to our records request you indicated that there was no validated cleaning procedure for the equipment used in the manufacture and…
3Stability and storage
Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)). In response to our request for a list all batches in stability and a list of all stability studies, you did not provide adequate stability data to demonstrate that the chemical properties of your drug products…
About this record
Extracted automatically from the document US FDA published on 2021-03-16. 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.
