FDA 483 - Sample Solutions, LLC - October 21, 2010

Sample Solutions, LLC, an OTC Drug Repacker in Olathe, CO, was inspected by the FDA, revealing significant deficiencies across multiple areas of Good Manufacturing Practices. The inspection found inadequate investigation procedures, a lack of equipment cleaning validation, and an absence of stability data for expiration dating. Additionally, the firm lacked sufficient written procedures for material receipt, employee training, and maintained an unsuitable facility for drug product operations.