Findings
1Process validation
Your firm failed to establish adequate 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)). Inadequate (b)(4) System Your firm uses (b)(4) as a component to manufacture OTC (b)(4) drug products. You failed to adequately validate your (b)(4) -production process to ensure that the system was producing (b)(4)…
2Quality unit oversight
Your firm failed to establish an adequate quality 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 (d). The records and information you provided demonstrate that your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. Specifically, your QU failed to: Ensure adequate control over laboratory data including…
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)). Your firm repeatedly failed to adequately perform identity testing of incoming high-risk components for (b)(4) contamination. In response to our December 15, 2023, FDA Warning Letter 320-24-13 pertaining to the 704(a)(4) records request, you committed to updating your specifications and ensuring robust and documented testing procedures for each…
About this record
Extracted automatically from the document US FDA published on 2026-03-17. 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.
