FDA 483 - Home Care Pharmacy of Palm Coast, Inc. - May 25, 2016

An FDA Form 483 was issued following an inspection, identifying multiple deficiencies in aseptic processing, environmental control, personnel practices, product testing, and record-keeping.

The facility's aseptic processing areas were deficient in cleaning and disinfection. On May 17, 2016, a technician cleaned the ISO 5 area using non-sterile wipes and an incorrect cleaning agent (sterile water instead of 70% IPA), failing to follow SOP 3.020. The technician also lacked sterile gowning, with exposed hair contacting ISO 5 surfaces. No sporicidal agent was used for ISO 5 cleaning, and application times for cleaning solutions were undefined or insufficient per manufacturer recommendations (e.g., 1-minute application for a 10-minute fungicidal effectiveness requirement).

Environmental monitoring of the ISO 5 area and operator gloves was only performed quarterly, with no daily monitoring or in-process monitoring during sterile drug product production. Personnel clothing was inappropriate; on May 17, 2016, the technician cleaning the ISO 5 area wore only non-sterile gloves and a face mask, lacking sterile hair nets, gowns, or shoe covers.

Sterile drug products, including Alprostadil, Bi-Mix, Tri-Mix, Quad-Mix, Droperidol, Glutathione, Hydroxocobalamin, and Sodium Hydroxide, were not adequately tested for endotoxin levels and bioburden