OraLabs LLC – FDA EIR, Jul 13, 2018

An FDA surveillance inspection of OraLabs, Incorporated, an Over-the-Counter (OTC) drug manufacturer in Parker, CO, was conducted from July 9-13, 2018. This inspection, carried out under the framework of Drug Manufacturing Inspections (CPGM 7356.002), focused primarily on the Quality and Laboratory Systems. The inspection identified four significant observations, leading to the issuance of an FDA-483 form. A key repeat violation was the firm's failure to thoroughly investigate unexplained discrepancies and Out-of-Specification (OOS) results for drug products, with investigations often lacking sufficient detail, scientific data, and root cause analysis. Secondly, laboratory records were found deficient as secondary verification of calculations (e.g., zinc oxide content) was not performed prior to product release. Thirdly, OraLabs lacked appropriate controls over computer systems and laboratory equipment software, which did not have secure log-ons or adequate audit trails, allowing for potential data deletion or overwriting. Lastly, the company failed to perform growth promotion testing on purchased microbiological media used for water testing, a component of OTC drug products, relying solely on manufacturer's Certificates of Analysis. Management, led by CEO Mr. Gary H. Schlatter, acknowledged the observations and committed to submitting a written response within 15 business days. Proposed corrective actions included hiring an investigation specialist and exploring new laboratory equipment to enhance data integrity.