Pine Pharmacy and Home Care Products Center, Inc. – FDA 483, Jul 19, 2013

The FDA Form 483 details multiple deficiencies observed during an inspection of a drug manufacturing facility.

**Facility and Operations:** The firm manufactures sterile injectable and ophthalmic drug products, including beta-Lactam non-penicillin drugs like Ceftazidime ophthalmic drops.

**Violations and Observations:**

* **Equipment Design (21 CFR 211.63):** The cleanroom design is inadequate to maintain ISO 5, ISO 7, and ISO 8 conditions. * Smoke studies were not performed under dynamic conditions to verify unidirectional airflow. * Vinyl strip door curtains at the ISO 7/ISO 8 and ISO 8/unclassified area entryways do not fully cover the doorways (approx. 2 feet open at bottom). * **Personnel Clothing (21 CFR 211.28(a)):** Non-sterile gowns are stored in open plastic bags in the ISO 8 anteroom. Non-sterile masks and bonnets are used, leaving facial skin exposed over the ISO 5 laminar flow bench, and no goggles are used. * **Microbiological Contamination Prevention (21 CFR 211.113(b)):** * Work surfaces inside the ISO 5 hood are not frequently tested for microbial contamination. Environmental monitoring by an outside contractor is infrequent (every (b)(4) for surfaces, (b)(