FDA EIR - Unifirst-First Aid Corporation - May 24, 2018

An FDA inspection of Unifirst First Aid Corp, a registered medical device repackager and relabeler of Class I and II first aid kits, was conducted from May 22-24, 2018. This inspection, carried out under CPGM 7382.845 for medical device manufacturers, verified that seven observations from a previous 2015 inspection had been successfully corrected.

However, the current inspection identified two new significant issues, resulting in an FDA-483 form. The main violations were: 1) Inadequate procedures for corrective and preventive actions (CAPA), specifically failing to include corrective actions for regulatory observations within their established CAPA system (referencing 21 CFR § 820.100(a)). 2) Failure to adequately evaluate customer complaints involving injuries to determine if they qualified for Medical Device Reporting (MDR) to the FDA (referencing 21 CFR § 820.198(a)). Examples included customer complaints of chemical burns and allergic reactions that were not properly assessed.

Management acknowledged these observations and committed to correcting them. They were provided 15 business days to submit a formal response and reminded of their responsibility to comply with the Food, Drug, and Cosmetic Act, with warnings of potential enforcement actions for non-compliance. Other verbally discussed items included the initial absence of a Quality Manual and a designated Management Representative (both addressed during the inspection), and general cleanliness of the assembly area.