FDA EIR - Guardian Drug Co. Inc. - February 17, 2022

An FDA inspection of Guardian Drug Co. Inc., located in Dayton, NJ, was conducted from January 26 to February 17, 2022. This unannounced inspection served as both a Pre-Approval Inspection for new drug applications and a For-Cause Current Good Manufacturing Practices (cGMP) inspection, guided by FDA compliance programs for drug process and pre-approval evaluations. Guardian Drug Co. contract manufactures, packages, and supplies OTC drugs, prescription drugs, and dietary supplements. At the inspection's conclusion, a seven-item Form FDA 483 was issued, citing significant deficiencies. Key violations included inadequate laboratory controls failing to assure drug product quality and purity, insufficient review of unexplained discrepancies and batch failures, and a lack of proper quality control unit review and approval for production records before product release. The inspection also identified issues with the absence of written procedures for master production record preparation, deficient equipment cleaning and maintenance procedures, and improper handling and storage of drug product containers. Furthermore, employees lacked adequate training for their assigned manufacturing functions. These observations indicate non-compliance with cGMP regulations, specifically 21 CFR 210/211. Guardian Drug Co.'s President and CEO committed to submitting a written response to the FDA within 15 business days addressing the identified deficiencies.