FDA EIR - OraLabs, Incorporated - January 10, 2020

An FDA surveillance inspection of OraLabs, Incorporated, a manufacturer of over-the-counter topical drugs, was conducted from January 6-10, 2020, in Parker, CO. The inspection, performed under the drug manufacturing regulatory framework adhering to current Good Manufacturing Practices, identified six significant observations documented on a Form FDA 483. Key issues included inadequate laboratory controls, specifically the absence of impurities testing for Benzocaine 5% Cream, a lack of statistical rationale for product release testing sample sizes, and a failure to ensure reference standards were equivalent to compendial standards. Furthermore, the company failed to maintain clean and adequately maintained production equipment; a dedicated mixer for benzocaine products was found with residue and its cleaning process unvalidated, and cleaning records were incomplete. Sanitation procedures were not consistently followed, with residue on mobile storage racks and dirty production floors. Production areas also suffered from poor maintenance, including damaged flooring, and improper storage of materials like cardboard boxes and chemical degreasers in production zones, indicating inadequate segregation. Finally, the Quality Assurance Unit did not adhere to its own change control processes or adequately conduct complaint investigations. OraLabs' CEO acknowledged the observations and committed to providing a written response detailing corrective actions to the FDA within 15 business days.