Findings
1Equipment and facility
Failure to perform repackaging, relabeling, or holding of API under appropriate CGMP to avoid mix-ups and loss of API identity or purity. Your firm failed to have adequate controls to prevent cross-contamination between API. Your functions included receipt, storage, weighing, repackaging, and relabeling of API in the same room using non-dedicated equipment and without appropriate procedures. During the inspection you initially stated that you did not repackage any highly…
2Quality unit oversight
Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP. Your firm lacked adequate quality unit (QU) oversight for the manufacture of your API. For example, your QU failed to: • Perform adequate testing and approve the results for your API prior to their release and distribution. You did not perform identity tests for your API to ascertain their quality. You relied solely on your supplier’s COA…
3Equipment and facility
Failure to adequately establish written procedures for cleaning equipment and its release for use in manufacture of API and validate written procedures for the cleaning and maintenance of equipment. Your firm failed to establish adequate written procedures for cleaning non-dedicated production equipment used for your API, some of which were highly potent. In addition, you failed to document the usage and cleaning of repackaging equipment. For example, you did not document…
About this record
Extracted automatically from the document US FDA published on 2021-08-03. 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.
