FDA 483 - Ash Stevens LLC - November 04, 2004

An FDA inspection of Ash Stevens Inc., an API manufacturer in Riverview, MI, revealed several deficiencies. Observations included incomplete analytical method transfer protocols, unverified raw material identity, uncontrolled access to laboratory HPLC systems, and a lack of written procedures for Excel spreadsheet use. Additionally, in-process test results were not recorded in batch records, and there was no formal agreement with contract testing laboratories defining GMP responsibilities.