# FDA 483 - Customcoatial Compounding, LLC - March 08, 2019

Source: https://www.keypedia.com/records/483/customcoatial-compounding-llc/4f701361-2ae3-4f4d-827f-0be98cd0d102

> FDA 483 for Customcoatial Compounding, LLC on March 08, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Customcoatial Compounding, LLC
- Inspection Date: 2019-03-08
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Customceutical Compounding, LLC in Phoenix, AZ, was inspected regarding its production of sterile and non-sterile drugs. The inspection revealed significant deficiencies in aseptic processing, environmental monitoring, personnel gowning, and cleaning procedures for sterile products. Additionally, the firm failed to prevent cross-contamination during the production of hazardous non-sterile drug products.

## Related Documents

- [483 - 2019-03-08](https://www.keypedia.com/records/483/customcoatial-compounding-llc/036208a6-552c-4743-83c2-220e2e0eb2af)

## Related Officers

- [Senior CSO, Investigator](https://www.keypedia.com/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)
- [Christopher M. Jenner](https://www.keypedia.com/people/christopher-m-jenner/d2fbd516-71aa-4263-8ffb-57b8149d6b64)

Company: https://www.keypedia.com/companies/customcoatial-compounding-llc/a64248b1-ed3d-402c-83a8-2a0efb554dc5

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face