FDA 483 - Coram Healthcare Corp. of Indiana - July 23, 2015

This FDA Form 483 document outlines several deficiencies observed during an inspection. The facility's operations show a lack of comprehensive written records for investigations into unexplained discrepancies, specifically regarding the inclusion of conclusions and follow-up actions.

Significant issues were noted in aseptic processing areas. The system for monitoring environmental conditions is deficient, and procedures to prevent microbiological contamination of sterile drug products are not adequately established, written, or followed. Furthermore, the systems for maintaining equipment used to control aseptic conditions are deficient, as is the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. Personnel clothing in these areas is not appropriate for their duties.

Beyond aseptic processing, the written stability testing program is not being followed. Critically, each batch of drug product purporting to be sterile and pyrogen-free is not consistently laboratory tested to confirm conformance to these requirements. These observations indicate deficiencies in quality control, environmental monitoring, personnel practices, and product testing, which are critical for ensuring the sterility and quality of drug products.