Findings
1Cleaning validation
Failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the APIs beyond the official or other established specifications. FDA documented rust-like residues inside (b)(4) non-dedicated (b)(4) used in the production of (b)(4) . In addition, FDA documented bare footprints inside another (b)(4) used in the production of (b)(4) . Each (b)(4) was labeled that it had been cleaned and was ready for use…
2Material and supplier control
Failure to test the identity of each batch of incoming production material. Your incoming raw material used to manufacture API intended for the U.S. market was not adequately tested. For example, you did not test the (b)(4) used as a raw material in the production of (b)(4) for identity. Your response is inadequate. You state that you “initiated the activity” to test (b)(4) for identity. However, you do not address whether all other raw materials are tested for identity or…
3Quality unit oversight
Failure to record all quality-related activities at the time they are performed. Your quality unit (QU) failed to ensure the integrity of CGMP records. For example, during the inspection, a member of your management stated that two of your operators admitted to falsifying temperature data for a drying oven that was not turned on during the manufacture of a (b)(4) batch, which later failed to meet the residual solvents specification. In addition, an Assistant Manager in…
About this record
Extracted automatically from the document US FDA published on 2025-02-18. 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.
