FDA 483 - Best Sanitizers Inc - October 16, 2015

Best Sanitizers Inc. in Walton, KY, a drug manufacturer, was cited for multiple deficiencies during an FDA inspection. Key issues include the absence of a written stability testing program, incomplete laboratory records lacking audit trails, and failures to document batch investigations for non-conformances. Additionally, the firm did not follow its complaint handling procedures, failed to validate automatic equipment for label reconciliation, lacked bilingual production procedures, and had no written procedures for handling returned drug products.