FDA 483 - Loop Plaza Pharmacy Company DBA Loop Compounding Pharmacy - December 16, 2016

The FDA Form 483 details multiple deficiencies observed during an inspection of a facility producing aseptically filled drug products.

**Facility and Operations:** The facility produces sterile injectable products, including Glycerin 98.5 Ophthalmic and intrathecal pain pump refills (morphine, hydrocodone, bupivacaine, baclofen). Operations involve ISO 5 laminar air flow benches, ISO 7, and ISO 8 rooms.

**Violations and Observations:**

* **Aseptic Processing Area Deficiencies:** * Cleaning of ISO 7, ISO 8 rooms, and ISO 5 benches lacks a sporicidal agent. * Drug spills in ISO 5 benches are cleaned with a previously used sterile spray bottle. * No data confirms adequate removal of smoke study residue from ISO 5 hoods. * Four dead bugs were found within a light fixture in the ISO 7 room. * Environmental monitoring in aseptic processing areas is deficient. * **Stability Testing Program Deficiencies:** * No written stability testing program exists. * Insufficient test data supports Beyond Use Dates (BUDs) for injectable products, including Glycerin 98.5 Ophthalmic (1-month refrigerated BUD). * No potency, sterility, or endotoxin data supports container closure systems for intrathecal pain pump refills stored in a freezer with multiple removals