Prescription Labs Inc dba Greenpark – FDA 483, Aug 12, 2021

This FDA Form 483 details multiple significant violations at a pharmacy engaged in sterile and non-sterile drug compounding.

**Facility and Operations:** The pharmacy produces sterile ophthalmic solutions (e.g., Vancomycin-PF, Spironolactone-PF, Tacrolimus-PF, Acetylcysteine Ophthalmic, Atropine Sulfate Ophthalmic) and injections (e.g., Testosterone Cypionate, Hydroxyprogesterone), as well as non-sterile creams (e.g., Biestrogen, Clobetasol). Operations involve ISO 5 Laminar Airflow Units (LAFUs) and Biological Safety Cabinets (BSCs) within cleanrooms.

**Violations and Observations:**

* **Aseptic Processing Breaches:** Personnel engaged in aseptic processing were observed with exposed facial skin (non-sterile helmet, eyeglasses, face mask) breaking the plane of the ISO 5 LAFU, directly impacting drug quality. This is a repeat observation. * **Product Quality and Release:** The firm released out-of-specification (OOS) drug products, dispensed products after their beyond-use date, and continued dispensing after receiving OOS laboratory results. * **Sterilization Deficiencies:** * Failure to conduct post-use filter integrity testing on sterile filters used for products like Spironolactone-PF Ophthalmic. This is a repeat observation, affecting 40 batches (10,000