1Cleaning validation
Your firm failed to validate the analytical methods required for the trace analysis of API residue as part ofthe cleaning validation program.
Inspection Record
Galaxy Surfactants Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
Your firm failed to place on stability at least one batch of manufactured APIs to monitor the stability characteristics of the API, and to test for appropriate storage conditions and confirm expiry dates.
3Training and personnel
You failed to provide appropriate GMP and position specific training to personnel for the particular operations that each employee performs as it relates to the employee's functions.
4Quality unit oversight
Your annual product review procedure is deficient such that: a.
About this record
Extracted automatically from the document US FDA published on 2018-06-26. 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.
