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

Source: https://www.keypedia.com/records/483/option-care-enterprises-inc-dba-option-care/c2672ad8-12ca-4ef4-8139-7f1ae6d7da83

> FDA 483 for Option Care Enterprises, Inc. dba Option Care on April 28, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Option Care Enterprises, Inc. dba Option Care
- Inspection Date: 2016-04-28
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: 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

## Related Documents

- [WARNING_LETTER - 2016-04-28](https://www.keypedia.com/records/warning_letter/option-care-enterprises-inc-dba-option-care/ff8a2e39-d97a-4fca-8d9a-7341759e8468)
- [483 - 2019-03-12](https://www.keypedia.com/records/483/option-care-enterprises-inc-dba-option-care/61ec5603-ec44-4309-9f21-91a306d75297)
- [STATE_REFERRAL_LETTER - 2019-03-05](https://www.keypedia.com/records/state_referral_letter/option-care-enterprises-inc-dba-option-care/11c0b44b-48bf-4578-bdb4-a5ddbb338d3f)

## Related Officers

- [Consumer Safety Officer at Commissioned Corps of the U.S. Public Health Service](https://www.keypedia.com/people/latorie-s-jones/086d0897-7d63-4fa8-bdce-f1d17885abd7)

Company: https://www.keypedia.com/companies/option-care-enterprises-inc-dba-option-care/03118350-b921-4d84-83a7-1b155f5516fc

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9