FDA 483 - Soaptronic LLC - April 28, 2025

An FDA inspection conducted between April 22 and April 28, 2025, identified significant compliance issues at a facility manufacturing Germstar brand over-the-counter (OTC) drug products, including hand sanitizers. The inspection resulted in an FDA Form 483, detailing ten observations indicating deviations from current Good Manufacturing Practices (cGMP).

Key findings revealed a systemic lack of control across various operational areas. In production, the firm failed to establish written procedures for process controls, specifically lacking validation for OTC drug product manufacturing, and did not consistently determine actual yield percentages for product batches. The quality system was deficient, with failures to thoroughly investigate out-of-specification results for active ingredients in stability studies and to conduct required annual product reviews. A repeat observation highlighted inadequate employee training on manufacturing Standard Operating Procedures (SOPs).

Furthermore, the material system showed a lack of qualification for raw material suppliers (ethanol, isopropyl alcohol, water). Packaging and labeling controls were compromised as labels for OTC products were stored in unlocked, uncontrolled cabinets. In the laboratory system, deficiencies included incomplete raw data records (pH, specific gravity, FTIR), uncalibrated gauges, and inadequate computer system controls, specifically the use of non-unique passwords for analytical instruments—another repeat observation.

These observations indicate a failure to ensure the identity, strength, purity, and quality of drug products. The manufacturer is expected to address these critical findings by implementing comprehensive corrective and preventive actions to achieve compliance with federal regulations.