Findings
1Laboratory and QC controls
Failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure your API complies with established specifications and standards. You failed to include complete data in your laboratory records for all laboratory analyses, and accordingly relied on incomplete information to determine whether your (b)(4) USP met established specifications. For example, you lacked documentation of the preparation of stock solutions…
2Stability and storage
Failure to design an adequate documented, on-going stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates. Your firm’s stability program is inadequate. Your firm failed to place at least one lot of your API manufactured in 2019, 2020, or 2021 on stability annually. In your response, you acknowledge that your stability procedure lacks specificity regarding…
3Laboratory and QC controls
Failure to ensure that, for each batch of API, appropriate laboratory tests are conducted to determine conformance to specifications. Based on review of your laboratory results, you failed to appropriately perform analytical testing (assay and LOI) of your (b)(4) USP in accordance to the current version of United States Pharmacopeia (USP) monograph, nor did you have data to support that your test method was equivalent or better than the USP method. In your response, you…
4Deviation, CAPA, and investigation
Failure to adequately investigate and document out-of-specification results and implement appropriate corrective actions. Your firm manufactures API (b)(4) USP, labeled in part to be the active ingredient used in (b)(4) . You failed to adequately investigate out-of-specification (OOS) test results. Specifically, your firm lacked adequate investigations and corrective actions for numerous OOS results obtained during laboratory testing of your API, including assay and loss on…
About this record
Extracted automatically from the document US FDA published on 2024-04-09. 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.
