FDA EIR - 2UD/DEV ,QFRUSRUDWHG - May 28, 2019

A routine surveillance inspection of OraLabs, Incorporated, a medical device manufacturer in Parker, CO, was conducted by the FDA from May 23 to May 28, 2019. The inspection focused on the firm's Quality System, specifically Corrective and Preventive Actions (CAPA), Design Controls, and Production and Process Controls, using the OraLabs Oral-B Nighttime Dental Guard as the review product. The inspection revealed two primary deficiencies. First, OraLabs had not established formal procedures for design control or design change control, as required by 21 CFR 820.30. The existing Design History File for their dental guard also failed to demonstrate compliance, lacking crucial elements such as risk analysis, design verification, validation, and design review. Second, the company's written Medical Device Reporting (MDR) procedures were inadequate, failing to meet requirements under 21 CFR 803.17. Specific issues included the absence of definitions for adverse events and MDR, clear timeframes for reporting, a standardized review process for determining reportability, and a mandate to evaluate all complaints for potential reportability. Additionally, during the inspection closeout, it was noted that the firm's Product Recall Procedure lacked several key regulatory requirements outlined in 21 CFR Part 806, concerning the reporting of reportable recall initiations to the FDA, specific notification timeframes (within 10 working days), and the required content for such reports, including expansions to existing recalls. Mr. Gary H. Schlatter, President/CEO, acknowledged these observations and committed to correcting them, promising a written response to the FDA within fifteen working days. Management was also cautioned about potential enforcement actions for unaddressed deficiencies.