FDA EIR - Apothecary Products, LLC - September 03, 2019

An FDA inspection of Apothecary Products, LLC in Burnsville, MN, occurred from August 27 to September 3, 2019, guided by the Compliance Program for Medical Device Manufacturers. The inspection identified significant issues within the company's quality system. Three primary violations were cited on an FDA-483 form. First, the company's procedures for accepting incoming product were inadequate, specifically lacking Certificates of Analysis for bulk silicone and using insufficient sample sizes for testing Ezy-Travel Wristbands, contrary to 21 CFR 820.80(b). Second, production and process controls were found deficient, as documented instructions and manufacturing work instructions were not established for key processes until recently, and operator training records were unavailable, violating 21 CFR 820.70(a). Third, calibration records for temperature controllers on blister sealing and thin film packaging machines were missing for 2016, failing to meet annual calibration requirements under 21 CFR 820.72(a). Verbal observations also highlighted a delayed Medical Device Report, a lack of proper document controls for internal audit schedules, and an absence of supplier approval records for a bulk silicone vendor prior to February 2019. Apothecary Products' management acknowledged all findings and committed to implementing corrective actions.