# Option Care – FDA Warning Letter, Jun 28, 2016

Source: https://www.keypedia.com/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 - 2017-08-02](https://www.keypedia.com/records/483/option-care/240d9fdd-fa49-4dcd-afad-b75d29b64e9e) — date: August 2, 2017
- [STATE_REFERRAL_LETTER - 2017-07-25](https://www.keypedia.com/records/state_referral_letter/option-care/47d9a697-1f04-42c9-9fb6-1e4295415f05) — date: July 25, 2017
- [483 - 2016-09-21](https://www.keypedia.com/records/483/option-care/e8d66211-8f86-49da-9643-fb83bae5776c) — date: September 21, 2016
- [WARNING_LETTER - 2016-09-21](https://www.keypedia.com/records/warning_letter/option-care/d9436677-453d-4f94-861a-04934506f939) — date: September 21, 2016
- [WARNING_LETTER - 2014-11-25](https://www.keypedia.com/records/warning_letter/option-care/f3833e81-d341-463d-bbe5-d60cb6ed208d) — date: November 25, 2014

## Related Officers

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

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

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