FDA 483 - Magellan Rx Pharmacy, LLC - December 22, 2016

This FDA Form 483 documents observations made during an inspection related to sterile operations. The facility exhibited inadequate aseptic practices and deficiencies in facility design and equipment use for sterile operations.

Regarding aseptic practices: (A) Personnel were observed donning sterile gloves in the non-classified anteroom. (B) Personnel failed to disinfect or change gloves frequently enough between compounding chemotherapy prescriptions. (C) Personnel engaged in aseptic processing left and re-entered the cleanroom from the non-classified anteroom without replacing gowning apparel. (D) Personnel used a non-sterile redacted inside the ISO 5 redacted hood, potentially contacting sterile IV delivery system components. (E) Personnel touched equipment/surfaces outside the ISO 5 redacted hood with gloved hands, then proceeded with aseptic processing without changing or sanitizing gloves. (F) An operator was observed wearing a loop earring in the cleanroom on December 8, 2016, not covered by gowning, contrary to Policy and Standards# OP.353.03-2015, effective April 11, 2015, requiring jewelry removal.

Regarding facility design and equipment use: (A) The facility design allowed non-classified air from the anteroom to influx into the ISO 7 cleanroom. (B) A sink was present in the cleanroom, approximately 12 feet from the ISO 5 redacted hood. (C