FDA EIR - Accupac, Llc - March 19, 2019

An FDA inspection of Accupac, Inc., a contract manufacturer of OTC drugs, medical devices, and cosmetics in Lakewood, NJ, took place from February 26 to March 19, 2019. The inspection evaluated compliance with Current Good Manufacturing Practices (cGMP) for drugs and medical device manufacturing regulations. A five-point FDA Form 483 was issued, highlighting significant deficiencies. For drug products, observations included inadequate documentation in batch production records, specifically failing to record critical steps such as the accurate addition of active ingredients in products like Zicam Extreme Congestion Relief Gel. Laboratory control systems were also cited; investigations into unexplained discrepancies (Out-of-Specification results) lacked complete conclusions and follow-up, with proposed corrective and preventative actions (CAPAs) not being implemented. Furthermore, instrument calibration procedures were not consistently adhered to, resulting in balances being used for measurements outside their calibrated ranges, affecting products like CeraVe Hydrocortisone Cream. Regarding medical devices, particularly Cidex OPA, Accupac's corrective and preventive action procedures were found to be insufficient. Multiple customer complaints about foreign material in Cidex OPA solutions lacked proper CAPA initiation, follow-up, or identification of particle origin. Additionally, complaints concerning potential device failure, labeling, or packaging issues were not thoroughly reviewed, evaluated, or investigated, with inadequate documentation to support root causes or visual inspection findings. Accupac management received the FDA Form 483 and verbally committed to addressing the observations, noting a "promise to correct" for the device-related issues. A comprehensive written response is formally required by the FDA within 15 working days.