Inspection Record
Inspectors Patty P Kaewussdangkul · Steven A BrettlerThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Processing areas are deficient regarding the system for monitoring environmental conditions.
Written procedures are not drafted, reviewed and approved by the appropriate organizational units.
The container labels of your outsourcing facility's drug products are deficient.
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
The labels of your outsourcing facility's drug products are deficient.
Extracted automatically from the document US FDA published on 2022-09-22. 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.
Growth stages previewSolve a quiz to start hatching
Your growth record is stored safely in this browser.
