Exela Pharma Sciences LLC – FDA 483, Jul 18, 2019

This FDA Form 483 details multiple observations regarding deficiencies in manufacturing practices and quality systems at a drug product facility.

**Facility and Operations:** The inspection observed compounding and filling operations for sterile drug products, including Norepinephrine Bitartrate Injection, USP, Lot Number PROT-000565, and Erythromycin Lactobionate (500 mg/vial), Lot CMHG1822. Operations occurred in Room 138 (Class 100,000), Room 139 (Class 10,000), Fill Line (b)(4) (Class 100), and Class 100 RABS (restricted access barrier system).

**Violations and Observations:**

* **Aseptic Processing Deficiencies:** * **Poor Aseptic Technique:** Operators frequently placed themselves over open product, reached across product, and had hair directly above open product. Equipment for monitoring (b)(4) was not disinfected before or between measurements, requiring submersion in product. During filling, an operator's head was inside the Class 100 RABS. Trays were exposed in Class 10,000 environment before entering Class 100. An operator rested wrists on trays at the Class 100/10,000 interface. Hand sanitization by an operator within the Class 100 (b