FDA 483 - Ash Stevens LLC - December 06, 2000

The FDA inspection of ASH STEVENS, INC. in Riverview, MI, an Active Pharmaceutical Ingredient Manufacturer, revealed significant deficiencies across multiple areas of quality control and manufacturing. The firm failed to complete cleaning validations for Brimonidine Tartrate and Floxuridine USP, lacked proper documentation for equipment cleaning, and did not ensure adequate employee training for cleaning procedures. Additionally, the inspection found issues with timely investigation of out-of-specification results and system suitability failures, incomplete analytical documentation, and a lack of qualification programs for outside testing laboratories, indicating a systemic breakdown in quality assurance practices.