FDA 483 - Park Infusioncare LP dba Preferred Homecare - July 11, 2017

During an FDA inspection, several observations were made regarding facility conditions and aseptic processing at the unnamed production facility. Vermin, specifically dead insects, were found in the production area: one on an ISO 5 Hood inside the Cleanroom, and two in refrigerators used for storing finished sterile products and drug ingredients.

The ISO 5 Hoods were noted to be poorly constructed for cleaning, with reddish-brown residue observed under the contact surface grating. The Anteroom ceiling tile also showed reddish-brown discoloration. A significant deficiency was a 1.5-inch gap at the bottom of the Anteroom door, exposing it to an unclassified area. Pressure gauge readings from October 20-31, 2016, indicated the Anteroom pressure differentials did not meet the firm's specifications of being greater than the Cleanroom and unclassified area. Materials were observed being transferred from the unclassified area to the Cleanroom via a pass-through during sterile drug product production.

Personnel aseptic technique was deficient: operators touched non-ISO 5 surfaces with gloved hands and continued aseptic processing without changing or sanitizing gloves. One operator opened the Cleanroom door to retrieve supplies from the Anteroom and re-entered the Cleanroom for sterile product preparation without glove changes or sanitization. Another operator improperly donned sterile gloves by touching the outside with bare hands.

Media fills were found to be inadequate, not simulating worst-case aseptic production operations. The current media