# FDA 483 - Pharmaron Manufacturing Services (US) LLC - January 23, 2020

Source: https://www.keypedia.com/records/483/pharmaron-manufacturing-services-us-llc/5a3f21c6-ae2b-4f2c-b8b4-1c52615ebda9

> FDA 483 for Pharmaron Manufacturing Services (US) LLC on January 23, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaron Manufacturing Services (US) LLC
- Inspection Date: 2020-01-23
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Rhodes Technologies, an Active Pharmaceutical Ingredient manufacturer in Coventry, RI, was cited for a significant quality control issue. The firm's Quality Control Unit failed to adhere to its own written procedures for the release of bulk liquid nitrogen, a critical production material. This involved a failure to properly complete required documentation and ensure QC Director confirmation of test results before material release.

## Related Officers

- [Program Division Director/District Director](https://www.keypedia.com/people/jonathan-g-matrisciano/17e5bce2-75a6-4182-925d-b94b42763dd2)

Company: https://www.keypedia.com/companies/pharmaron-manufacturing-services-us-llc/ae7512a8-bd98-4a34-a61e-4c3bc455ed65

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94