# FDA 483 - homechoice partners, inc.  - September 19, 2018

Source: https://www.keypedia.com/records/483/homechoice-partners-inc/eb8f434c-e567-43d8-a9db-625bdae4174b

> FDA 483 for homechoice partners, inc.  on September 19, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: homechoice partners, inc. 
- Inspection Date: 2018-09-19
- Product Type: Drugs
- Office Name: Kansas City District Office
- Summary: From September 10-19, 2018, the FDA inspected HomeChoice Partners, Inc. dba Bioscrip Infusion Services, a producer of sterile drug products located at 528 Trade Center Blvd, Chesterfield, MO. The inspection, led by Investigator Tiara N Brown-Crosen, resulted in two observations detailed in Form 483 issued to General Manager Joshua R. Clinard.

Observation 1 noted the production of beta-lactam drugs (e.g., Ceftriaxone, Cefazolin) in the same ISO 5 area as non-beta-lactam drugs without adequate cleaning of work surfaces to prevent cross-contamination. The firm's cleaning procedure lacked identification of appropriate cleaning agents for this purpose.

Observation 2 detailed instances where personnel touched surfaces outside the ISO 5 aseptic processing area with gloved hands and then continued aseptic processing without changing or sanitizing gloves. Specifically, on September 10, 2018, during the production of Tigecycline, Vancomycin, Ceftriaxone, and Cefazolin, a technician touched a supply cart and operated a fluid dispensing pump in the ISO 7 IV Room, then continued aseptic processing in the ISO 5 LFH without glove change or sanitization.

## Related Documents

- [WARNING_LETTER - 2018-08-17](https://www.keypedia.com/records/warning_letter/homechoice-partners-inc/ca6d81d2-299c-405a-a9af-78a818f2418f)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/tiara-m-brown/bbc93754-69de-4379-b9f5-f85ea4c8b0e9)

Company: https://www.keypedia.com/companies/homechoice-partners-inc/5c505bac-c7e0-42ed-8378-aa6faca92a09

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79