american pharmacy of illinois, inc. – FDA 483, Jul 17, 2018

The FDA Form 483 details multiple observations during an inspection. Non-sterilized and non-depyrogenated amber bottles, rubber stoppers, and aluminum seals were used for sterile human drug products, including Hydroxyprogesterone 250 mg/ml Injection and Progesterone 100 mg/ml Injection, without prior sterilization or pyrogen removal. Materials were not adequately disinfected before entering aseptic processing areas; a pharmacy technician was observed disinfecting vials with a single wipe motion.

The facility produced highly potent non-sterile drugs using a (b)(4) mixer that was cleaned with laboratory-grade cleaner and tap water, raising concerns about cross-contamination. Examples include Quetiapine 100 mg/ml Suspension and Guaifenesin SR 600 mg Capsules. Facility design allowed poor quality air into higher classified areas; a (b)(4) pass-through between a non-classified non-sterile room and an ISO 7 room was constructed of unsuitable material, potentially allowing unclassified air into the ISO 7 room and subsequently the ISO 5 hood during sterile drug preparation.

A non-pharmaceutical grade component, (b)(4), was used in the formulation of non-sterile drug products, specifically Dental Anesthetic Gel. The firm lacked assurance of endotoxin levels for intrathecal drug products, as no endotoxin testing was performed on finished products or active pharmaceutical ingredients (APIs), despite using non-sterile starting materials