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. Our inspection documented approximately 84 open and past due deviation investigations existed as of June 21, 2024. For example: A. QE-000270 (187 days past due) B. QE-004069 (179 days past due) C. QE-004896 (129 days past due) D. QE-023790 (45 days past due) Multiple past due investigations also lacked procedurally required extensions to…
2Contamination control
Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes. You repeatedly deviated from your validated manufacturing process for the production of (b)(4) . For example: A. You performed (b)(4) of the (b)(4) during (b)(4) of the (b)(4) bioreactor runs while the manufacturing process was validated with (b)(4) . You identified the (b)(4) process as increasing the risk of microbiological contamination…
3Documentation and records
Failure to ensure all production deviations are reported and evaluated, and that critical deviations are investigated, and the conclusions are recorded. Multiple production deviations went unaddressed until our investigators informed facility personnel of the issues. For example: A. An (b)(4) line used for aseptic processing was observed to be touching the floor during (b)(4) setup activities. The batch record specifically includes an instruction for personnel to ensure…
4Equipment and facility
Failure to have equipment of the appropriate design and suitability for their intended use for the manufacture of APIs. Your firm used equipment unsuitable for its intended use in microbiologically controlled manufacturing environments. For example: A. Mobile carts used in the setup of (b)(4) units required operators to get down to the floor and manually lock and unlock the cart brakes despite previously determining equipment proximity to the floor as a contributing root…
5Deviation, CAPA, and investigation
Failure to investigate all critical deviations. FDA documented that approximately 20 percent of bioreactor runs attempted between January 2022 and July 2024 were rejected for contamination or other quality failures. This rate is excessive and calls into question the state of control of your process. You failed to conduct adequate investigations into critical deviations, including multiple microbiological contamination events recorded in this timeframe. For example: A. Two…
About this record
Extracted automatically from the document US FDA published on 2025-01-21. 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.
