FDA 483 - Perry Drugs Inc. - September 09, 2014

This FDA Form 483 document outlines several significant deficiencies observed during an inspection of a drug manufacturing facility. The facility produces drug products purporting to be sterile, but critical procedures and controls are lacking.

A primary concern is the absence of validation for the sterilization process, which is essential for ensuring the sterility of drug products. Furthermore, each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to confirm conformance to these requirements.

Deficiencies were also noted in the aseptic processing areas. The system for cleaning and disinfecting the room and equipment to produce aseptic conditions was found to be inadequate. Similarly, the system for monitoring environmental conditions within these aseptic processing areas was deficient.

Personnel clothing was also cited as inappropriate for the duties performed in the manufacturing, processing, packing, and holding of drug products, raising concerns about potential contamination. Finally, the facility lacks a written testing program designed to assess the stability characteristics of its drug products, which is crucial for determining shelf-life and product quality over time. These observations indicate significant issues with quality control, manufacturing processes, and overall compliance with sterile drug product regulations.