# FDA 483 - Custom RX LLC - August 15, 2017

Source: https://www.globalkeysolutions.net/records/483/custom-rx-llc/b5b729a9-4f81-4c30-acfa-36cf5ce58955

> FDA 483 for Custom RX LLC on August 15, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Custom RX LLC
- Inspection Date: 2017-08-15
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Custom RX, LLC in Wichita, KS, revealed significant deficiencies in aseptic processing and facility cleaning. Observations included an operator spraying gloves over open sterile drug product vials and media fills not representative of production. Additionally, the firm failed to adequately clean the ISO 5 hood after smoke studies and used commercial dish soap for sterile glassware.

## Related Documents

- [483 - 2017-08-15](https://www.globalkeysolutions.net/records/483/custom-rx-llc/d0ca9295-678b-4162-a24c-2057c110efab)

## Related Officers

- [Rita Kabaso](https://www.globalkeysolutions.net/people/rita-kabaso/a8383d6d-b945-4edc-97a4-90944574835d)

Company: https://www.globalkeysolutions.net/companies/custom-rx-llc/a9e8a808-9d8f-4f8a-b55f-1dba991a71c7

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8