FDA 483 - Option Care Enterprises, Inc. dba Option Care - April 28, 2016

The FDA Form 483 details numerous deficiencies at a facility producing sterile drug products, including approximately 10,000 orders (20,000 units) dispensed from January to April 2016.

Key violations include: - **Aseptic Processing Area Deficiencies:** The ISO 8 Ante Room lacked a HEPA filter, which was removed on January 7, 2016. The room was last certified as ISO 8 on (b)(4). - **Cleaning and Disinfection System Deficiencies:** The ISO 7 Buffer Room floor was uneven with numerous epoxy-filled areas. Hoods (b)(4) and (b)(4) had whitish-yellowish/white residue buildup and rust-colored spots on HEPA filters. A HEPA filter in the ISO 7 Buffer Room had two blackish areas. Empty (b)(4) in the ISO 7 Buffer Room contained lint after cleaning. Non-sterile, non-sporicidal (b)(4) was used beyond manufacturer instructions for cleaning ISO 5, 7, and 8 areas. - **Microbiological Contamination:** The firm continued producing sterile drug products despite positive viable air test results on (b)(4). - **Operator Practices:** Operators failed to clean rubber (b)(4) of the (b)(4) in Hood (b)(4). Improper sterile glove donning was observed, with operators touching critical