FDA 483 - PETNET Solutions, Inc. - December 02, 2025

An FDA inspection, conducted from late November to early December 2025 and issued on December 4, 2025, identified significant deficiencies at a pharmaceutical manufacturing facility (company name redacted). The observations, made under the Federal Food, Drug, and Cosmetic Act, highlight critical concerns in both laboratory control and facilities management, potentially impacting the safety and quality of sterile PET drug products.

The primary issues involved the company's laboratory control system, specifically with Gas Chromatography (GC) equipment. The firm experienced over 100 repeat system suitability failures for its GC equipment without conducting root cause investigations. Instead, initial failing runs were invalidated, and subsequent successful runs were accepted, raising questions about the reliability of test results for critical drug products.

Furthermore, deficiencies in the facilities and equipment system revealed a failure to adequately implement and document cleaning procedures. Specific concerns included operators not sanitizing gowning sleeves before re-entering ISO classified areas, leading to potential contamination of sterile product assembly surfaces. The company also failed to document disinfectant contact times as required by its own procedures, hindering assurance of effective sanitation. Lastly, there was a lack of established controls for ready-to-use disinfectant spray bottles, allowing improper handling and increasing the risk of cross-contamination.

These observations indicate conditions that could compromise the identity, strength, quality, or purity of drug products. The company is required to review these findings and submit a detailed plan outlining comprehensive corrective actions to address each identified deficiency.