OraLabs LLC – FDA 483, Dec 18, 2015

An FDA inspection of OraLabs, Incorporated, an OTC manufacturer in Parker, CO, revealed significant deficiencies in laboratory controls, equipment maintenance record-keeping, discrepancy investigations, and adherence to sampling and testing procedures. These issues indicate a lack of robust quality systems and control over drug product manufacturing and testing. The firm failed to adequately investigate rejected media, maintain complete equipment logs, review batch discrepancies, and follow correct testing methods.