Findings
1Deviation, CAPA, and investigation
Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP. Investigation Handling Your QU failed to ensure that discrepancies and potential OOS events were adequately investigated. Your firm has manufactured and distributed approximately (b)(4) batches since April 2023. While your firm has not documented any OOS investigations, out-of-trend investigations, or laboratory incidents over at least the…
2Process validation
Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes. Inadequate Process Validation Your firm failed to establish adequate process validation for clomiphene citrate USP and its key starting materials. Your process validation reports do not accurately reflect actual manufacturing practices. For example, your validation reports fail to address the (b)(4) operation. Also, your validations do not…
3Data integrity
Failure to ensure that all specifications, sampling plans, test procedures are scientifically sound and appropriate to ensure that your API conform to established standards of quality and purity. Your firm manufactures the API, clomiphene citrate USP for U.S. distribution, intended for pharmacy compounding. Data Integrity Concerns Your firm failed to establish adequate controls over analytical testing data. Multiple instances of unreported sample injections for related…
About this record
Extracted automatically from the document US FDA published on 2026-07-21. 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.
