Findings
1Material and supplier control
Your firm failed to test samples of each component for specific identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)). Your firm manufactures over-the-counter (OTC) drug products, such as (b)(4) . You failed to perform adequate identity testing on each incoming component lot used in the manufacture of your drug products, including for (b)(4) and the active ingredient (b)(4) . (b)(4) Your…
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)). Your firm failed to adequately validate the manufacturing process for your drug product. You do not have assurance that you are capable of consistently manufacturing your drug product with defined quality attributes. Your…
3Laboratory and QC controls
Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)). You failed to establish the adequacy of release testing procedures, and you released batches of drug products for distribution without conducting adequate testing to confirm critical quality attributes. For example, you did not use USP chemical and microbiological methods to test incoming drug substance or to test and release…
4Stability and storage
Your firm failed to establish and follow a 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)). Your firm failed to establish an adequate stability program, which includes data from long-term or accelerated storage conditions to demonstrate that your product remains acceptable throughout its labeled expiry period…
About this record
Extracted automatically from the document US FDA published on 2025-08-19. 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.
