Failure to clean equipment at appropriate intervals to prevent build-up and carryover of contaminates and degradants where equipment is assigned to continuous production or campaign production of successive batches of the same intermediates and API. A. Equipment cleaning (b)(4) used in the (b)(4) synthesis were observed with brownish rust like spots on the upper walls of the (b)(4) with layers of thick black spots above the brownish spots. These layers of black and brown…
2Deviation, CAPA, and investigation
Failure to extend investigations to other batches that may have been associated with a specific failure or deviation. Your investigation of the (b)(4) impurity in (b)(4) active pharmaceutical ingredient (API) is deficient. Though you identified at least four lots that failed your (b)(4) impurity specification, you did not extend your investigation to all lots manufactured prior to August 2018 after you identified (b)(4) had a higher risk of forming. Your investigation was…
3Other quality system
Failure to establish an impurity profile for identified and unidentified impurities. Your firm failed to conduct a comprehensive evaluation of the manufacturing process to identify all potential impurities. A. (b)(4) impurity (b)(4) Your firm failed to perform a systematic evaluation of the manufacturing process of (b)(4) API and have robust procedures to identify the potential formation of (b)(4) impurity. On July 6, 2021, you were notified of the presence of the (b)(4)…
About this record
Extracted automatically from the document US FDA published on 2022-09-27. 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.
