# FDA WARNING_LETTER - Option Care - June 28, 2016

Source: https://www.globalkeysolutions.net/records/warning_letter/option-care/9ff16d33-b74b-4d3c-a5f7-5017744dccac

> FDA WARNING_LETTER for Option Care on June 28, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Option Care
- Inspection Date: 2016-06-28
- Product Type: Drugs
- Office Name: New Jersey District Office
- Summary: On July 20, 2017, the FDA issued a Warning Letter to Option Care Enterprises, Inc. dba Option Care, following an inspection from June 20-28, 2016, at their Columbia, MD facility. The inspection revealed serious deficiencies in sterile drug product production, leading to adulterated drug products under section 501(a)(2)(A) of the FDCA.

Violations included insanitary conditions: using non-sterile wipes and disinfectant in aseptic areas, observed rust and residue on an ISO 5 hood grill, a technician contaminating gloves/gown by reaching into a trash container and continuing work without sanitization, and materials brought into the ISO 5 hood without prior disinfection. Additionally, media fills did not adequately simulate aseptic operations, including worst-case activities.

Option Care's July 20, 2016, response to the FDA-483 was partially inadequate. The firm incorrectly stated that sterile wipes and disinfectants are not required by state regulations or USP <797>, which the FDA refutes as increasing contamination risk. Some proposed corrective actions lacked supporting documentation, such as cleaning the ISO 5 hood and changing aseptic validation kits.

The FDA strongly recommended a comprehensive assessment of operations, particularly aseptic processing, with assistance from a third-party consultant. Failure to promptly correct violations may result in legal action. Option Care must respond within fifteen working days, detailing corrective actions

## Related Documents

- [483 - 2016-09-21](https://www.globalkeysolutions.net/records/483/option-care/e8d66211-8f86-49da-9643-fb83bae5776c)
- [STATE_REFERRAL_LETTER - 2017-07-25](https://www.globalkeysolutions.net/records/state_referral_letter/option-care/47d9a697-1f04-42c9-9fb6-1e4295415f05)
- [483 - 2014-11-25](https://www.globalkeysolutions.net/records/483/option-care/813b9462-fb56-4e5d-95b8-0ecb5aecd048)
- [145 - 2020-07-01](https://www.globalkeysolutions.net/records/145/option-care/c2f2a9da-be78-45d2-b40c-4a9ecf756662)
- [145 - 2018-04-12](https://www.globalkeysolutions.net/records/145/option-care/5f5bd4d4-dac3-459c-9504-5061bbb8919d)

## Related Officers

- [District Director](https://www.globalkeysolutions.net/people/diana-amador-toro/66f3f6c5-4cfe-4f40-b4d4-d24ed4618e64)

Company: https://www.globalkeysolutions.net/companies/option-care/3e9b5d79-2178-48b6-86e8-000ee6bc9144

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248