Pentec Health – FDA Warning Letter, Apr 1, 2013

On March 7, 2014, the FDA issued a Warning Letter to Pentec Health, Inc. following an inspection from March 18 to April 1, 2013. The inspection revealed serious deficiencies in the production of sterile drug products, leading to the classification of products as adulterated under section 501(a)(2)(A) of the FDCA.

Key violations included unacceptable aseptic practices, such as placing supplies in ISO 5 hoods without disinfection and personnel performing manipulations directly over open containers, obstructing unidirectional airflow. Additionally, the firm failed to demonstrate adequate protection of the ISO 5 area through appropriate studies, specifically lacking dynamic smoke studies in ISO 5 hoods where large equipment is used. These issues create insanitary conditions and a significant contamination risk.

An FDA Form 483 was issued on April 1, 2013, and the firm subsequently recalled 163 units of product lacking sterility assurance. While Pentec Health, Inc. responded to the 483 and hired a consultant, the FDA deemed the planned corrective actions insufficient. The FDA strongly recommended a comprehensive assessment of all operations, particularly aseptic processing. The company was given 15 working days to respond in writing with specific corrective actions, a plan to prevent recurrence, and supporting documentation. Failure to comply could result in legal action, including seizure and injunction.