Findings
1Process validation
Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes. Inadequate Process Validation You failed to adequately validate your (b)(4) API manufacturing process. For example, your process validation lacked a scientific rationale for not including the smallest batch size your firm manufactures, a defined sampling plan for each stage, and testing requirements for raw materials used. In addition, your…
2Laboratory 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. Inadequate Testing of (b)(4) API You failed to adequately test your (b)(4) USP (b)(4) API per the current USP monograph. For example, you did not conduct testing for “ (b)(4) ” and “ (b)(4) .” These tests are not required in your API specification. As a result, you distributed lots of (b)(4) API to the…
3Documentation and records
Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP. Poor Documentation Practices Your firm manufactures (b)(4) USP (b)(4) API. Your quality unit (QU) failed to implement adequate controls to ensure the integrity of data generated at your facility. Our investigators observed unacceptable documentation practices, including, but not limited to, the following: torn batch records, a torn testing…
4Material and supplier control
Failure to test the identity of each batch of incoming production material and to appropriately qualify suppliers to rely upon their certificate of analysis. You failed to conduct an identity test on each lot of raw material used in the manufacture of your API. You instead relied on the certificates of analysis (COAs) from your suppliers without adequately qualifying them. You tested (b)(4) , received as your primary raw material, for some quality attributes; however, an…
5Equipment and facility
Failure to properly maintain buildings and facilities used in the manufacture of API. Facility Conditions You failed to maintain your drug manufacturing facility in a good state of repair. The washroom used by operators was observed to be heavily soiled, and soap for handwashing was not available. In addition, the gowning room was observed to have dirty lockers, garments, and operator shoes. Visibly soiled cloth gloves, which come into direct product contact with the (b)(4)…
About this record
Extracted automatically from the document US FDA published on 2025-05-13. 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.
