Option Care – FDA 483, Sep 21, 2016

This FDA Form 483 document details observations from an inspection concerning the preparation, packing, or holding of a finished drug product under insanitary conditions, potentially leading to contamination or rendering it injurious to health. The primary concern is the lack of appropriate controls to prevent contamination of sterile drug products.

Specific violations include: 1. **Improper Gowning Procedures:** Personnel donned gowning apparel improperly, potentially causing contamination. 2. **Inadequate Gowning Storage and Donning Area:** Gowning worn for aseptic operations (eyewear, hair bonnets, beard covers, face masks, lab coats/coveralls) is stored and donned in the ante-room where the hand sink is located, contrary to the firm's policy (b)(4). 3. **Disruption of Airflow in Sterile Areas:** Personnel were observed moving rapidly near open sterile units or instruments, disrupting airflow and increasing the risk of introducing lower quality air into the ISO 5 area. 4. **Concurrent Operations in ISO 5 Area:** On 9/1/2016, employees were observed (b)(4) drug products in ISO 5 LAF hoods while other in-process components awaited aseptic production in the same area. The National Manager of Pharmacy Operations, S.K., indicated this practice was for (b)(4) of some products.

These observations highlight deficiencies in the facility's quality system and manufacturing controls, specifically regarding aseptic processing