Findings
1Laboratory and QC controls
Failure to ensure that all specifications and test procedures are scientifically sound and appropriate to ensure that your API conform to established standards of quality and purity. You manufacture (b)(4) API that was imported into the United States and supplied to (b)(4) . This drug is commonly used (b)(4) . You failed to establish that your test methods for testing (b)(4) are scientifically sound, and that your specifications for (b)(4) are appropriate. Your test method…
2Cleaning validation
Failure to establish adequate written procedures for cleaning equipment and its release for use in manufacture of API. Your cleaning validation for your shared manufacturing equipment for (b)(4) APIs is inadequate. You provided a protocol for cleaning the (b)(4) tank used to manufacture (b)(4) , which does not include acceptance criteria for carryover residues. Instead, you relied on visual inspection to determine cleanliness of your equipment and could not provide any…
3Quality unit oversight
Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility is in compliance with CGMP. You lack adequate quality unit (QU) oversight for the manufacture of your API. Your QU failed to ensure that there was adequate stability data to support retest or expiration dates of API manufactured at your facility. You have inadequate stability data to support the (b)(4) retest date for (b)(4) . While you provided stability data tables…
About this record
Extracted automatically from the document US FDA published on 2025-02-11. 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.
