FDA 483 - Precare Corp - October 09, 2025

Precare Corp, a drug manufacturer in Hauppauge, NY, received an FDA Form 483 following an inspection from October 6-9, 2025, detailing several significant departures from current Good Manufacturing Practice (cGMP) regulations. The observations primarily centered on deficiencies in their quality control and production systems. Key issues included inadequate laboratory controls, such as failing to perform critical testing for Burkholderia cepacia complex and other raw material components for non-sterile over-the-counter (OTC) drug products. The firm also lacked a robust stability program, failing to establish appropriate expiration dates through sufficient batch testing and ongoing stability monitoring.

Further observations highlighted inadequate equipment cleaning and maintenance, with deviations from established standard operating procedures, absence of defined clean and dirty hold times, and an incomplete cleaning validation program. The quality control unit exhibited several shortcomings, including improper segregation and control of rejected and quarantined materials, unsecured labeling components, and a failure to conduct comprehensive annual product reviews. Additionally, the firm did not adequately control laboratory computer systems, lacking full system audit trail reviews. Lastly, Precare Corp failed to conduct annual visual inspections of retain samples for OTC drug products and did not consistently calibrate production scales before use. The company is required to implement thorough corrective and preventive actions to address these findings and achieve full regulatory compliance.