# FDA 483 - HomeChoice Partners dba BioScript Infusion Services - August 17, 2018

Source: https://www.keypedia.com/records/483/homechoice-partners-dba-bioscript-infusion-services/146fa603-20e3-4d9a-b9ef-4d94d6f4da0c

> FDA 483 for HomeChoice Partners dba BioScript Infusion Services on August 17, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HomeChoice Partners dba BioScript Infusion Services
- Inspection Date: 2018-08-17
- Product Type: Drugs
- Office Name: Atlanta District Office
- Summary: This FDA Form 483 was issued to HomeChoice Partners, Inc., a producer of sterile drug products, located at 2848 Washington Rd, Augusta, GA 30909-2356. The inspection was conducted from August 13-17, 2018, and the report was issued to David H. Jones, Pharmacy Manager.

Two observations were noted:

1.  **Deficient Aseptic Processing Area Cleaning and Disinfection:** The system for cleaning and disinfecting equipment to produce aseptic conditions was found deficient, posing a risk to the sterility of the ISO 5 Laminar Flow Hood. Specific issues included:
    *   Use of non-sterile gowns during sterile drug product production in the ISO 5 Laminar Flow Hood.
    *   Failure to sanitize tubing connected to stock solutions in the ISO 5 Laminar Flow Hood between the production of different sterile drug products. An example on August 14, 2018, showed a Sterile Compounding Technician touching tubing multiple times without sanitizing it before producing a different drug.
    *   Sterile wipes introduced for daily cleaning were left open and exposed in the ISO-5 area before, during, and after cleaning.

2.  **Pest Infestation in Manufacturing Buildings:** Buildings used for drug product manufacture, processing, packing, or holding were not free of infestation. During cleanroom cleaning, two live insects were observed

## Related Documents

- [483 - 2018-08-17](https://www.keypedia.com/records/483/homechoice-partners-dba-bioscript-infusion-services/8f22ebfe-647c-4d58-879d-6009b2988ca3)
- [483 - 2021-08-09](https://www.keypedia.com/records/483/homechoice-partners-dba-bioscript-infusion-services/152ebc2c-c141-49da-8d5e-043c2dee9246)
- [STATE_REFERRAL_LETTER - 2021-08-02](https://www.keypedia.com/records/state_referral_letter/homechoice-partners-dba-bioscript-infusion-services/f5737826-c558-4b2d-b7bc-c299f6fb19d6)

## Related Officers

- [Johnetta F. Walters](https://www.keypedia.com/people/johnetta-f-walters/61bdf49d-888c-4a02-976f-5cb00aff0fa9)
- [Policy Analyst](https://www.keypedia.com/people/tamara-j-henderson/9ccc2ac9-9d39-4bd6-8c6e-b9bae9e82554)

Company: https://www.keypedia.com/companies/homechoice-partners-dba-bioscript-infusion-services/2033b1d3-4a0c-4ca0-ace7-71940400400c

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7