FDA 483 - Specialty Compounding, LLC - March 22, 2013

This FDA Form 483 details observations from an inspection, highlighting significant deficiencies in the facility's sterile drug product manufacturing.

**Facility and Operations:** The firm prepares various injectable and inhalation drug products, including Magnesium Sulfate, Acetylcysteine, Bupivacaine Hydrochloride, DMPS, Cefazolin, Furosemide, Morphine Sulfate, Calcium Gluconate, Hydromorphone, Fentanyl, Sodium Phenylbutyrate, Glutathione/Adenosine Triphosphate, Hydrogen Peroxide, Methylcobalamin, and Methylcobalamin/Folic Acid. Operations involve ISO 5 Laminar Flow Hoods (LFH), ISO 7 clean rooms, and ISO 8 prep/ante rooms.

**Violations and Observations:** 1. **Microbiological Contamination Prevention:** Procedures are not established to prevent contamination. * Employees touched bare skin with gloved hands, then resumed filling operations (e.g., Magnesium Sulfate, Acetylcysteine) without changing gloves. * A pharmacist knelt on the ISO 7 clean room floor to retrieve items, then continued working without re-gowning or changing gloves, handling components for multiple products (e.g., Bupivacaine, DMPS). 2. **Personnel Gowning:** Clothing is inappropriate. * Gowning attire (bunny suit with foot covers, single hair net, safety glasses, single ear-loop mask, single pair