FDA 483 - Medivera Compounding Pharmacy - November 13, 2014

This FDA Form 483 document outlines several deficiencies observed during an inspection, primarily concerning the manufacturing of sterile drug products. The facility's operations are cited for not having established procedures to prevent microbiological contamination of sterile drug products.

Personnel clothing is deemed inappropriate for their duties in drug product processing. The aseptic processing areas are deficient in two key aspects: the system for monitoring environmental conditions and the systems for maintaining equipment used to control aseptic conditions.

Furthermore, the document notes the absence of a written testing program to assess the stability characteristics of drug products. Container closure systems are found to be inadequate, failing to provide sufficient protection against foreseeable external factors that could lead to deterioration or contamination. Finally, each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to confirm conformance to these requirements. These observations indicate significant issues within the facility's quality system and manufacturing controls for sterile products.