Chattem Inc – FDA EIR, Mar 13, 2020

An FDA cGMP surveillance inspection of Chattem Plant 1, a cosmetic and over-the-counter drug manufacturer, was conducted from March 9 to March 13, 2020. The inspection focused on quality, facilities and equipment, materials, production, and laboratory control systems. The inspection revealed one significant objectionable condition, resulting in the issuance of an FDA Form 483. The primary violation cited was that equipment and utensils were not maintained at appropriate intervals to prevent malfunctions that could compromise the safety, identity, strength, quality, or purity of drug products. Specific issues observed included multiple water leaks in Plant 2 and Plant 3's purified water systems, which are critical for manufacturing OTC creams, ointments, and liquid products. Investigators also noted dirty filter media on a Plant 2 packaging line and identified that scheduled preventive maintenance for a Plant 3 purified water system had not been performed. Such lapses in maintenance could potentially impact product quality. These findings constitute a violation of current Good Manufacturing Practices (cGMP) regulations, specifically 21 CFR 211.67(a). An FDA Form 483 detailing these observations was issued to the Site Head, requiring a formal written response within fifteen days. During the inspection, Chattem initiated several voluntary corrections, such as repairing some leaks, replacing the dirty filter, and initiating work orders for other identified issues.