FDA 483 - QuVa Pharma, Inc. - January 23, 2015

This FDA Form 483 document outlines several deficiencies observed during an inspection related to the manufacturing of sterile drug products. The facility's procedures designed to prevent microbiological contamination of these products are not adequately established.

Significant issues were noted within the aseptic processing areas. The system for monitoring environmental conditions in these areas is deficient. Furthermore, the system for cleaning and disinfecting the room and equipment to produce aseptic conditions is also deficient.

Regarding quality system documentation, written records of investigations into unexplained discrepancies were found to be incomplete, specifically lacking conclusions and follow-up actions.

Finally, the facility's separate or defined areas, crucial for preventing contamination or mix-ups, are deficient concerning operations related to the aseptic processing of drug products. These observations indicate a need for improved controls and documentation within the sterile manufacturing operations.