Findings
1Quality unit oversight
Failure of your quality unit to exercise its responsibility to ensure the API and intermediates manufactured at your facility are in compliance with CGMP. Your quality unit (QU) failed to perform identity testing on incoming raw materials used in the manufacture of APIs (b)(4) , which are intended for use in pharmacy compounding. Specifically, your firm intentionally accepted lots of (b)(4) that were deliberately mislabeled by your supplier as (b)(4) . During the inspection…
2Cleaning validation
Failure to clean equipment to prevent contamination or carry-over of a material that would alter the quality of the intermediates and API beyond the official or other established specifications. Your firm failed to adequately clean and maintain non-dedicated API manufacturing equipment used to manufacture as many as (b)(4) different APIs. For example, our investigator observed (b)(4) and (b)(4) particles on product contact surfaces, including the lid and (b)(4) of (b)(4)…
3Laboratory and QC controls
Failure to ensure that all test procedures are scientifically sound and appropriate to ensure that your intermediate and API conform to established standards of quality and purity. Your firm failed to validate or adequately verify multiple test methods used for testing key starting materials and finished APIs. Specifically, you did not validate the in-house analytical methods, including the stability-indicating methods, used to support the (b)(4) retest dates for your…
About this record
Extracted automatically from the document US FDA published on 2026-07-21. 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.
