# FDA 483 - Immunex Rhode Island Corporation - December 07, 2021

Source: https://www.globalkeysolutions.net/records/483/immunex-rhode-island-corporation/120e9273-7a08-4e38-914b-201969361429

> FDA 483 for Immunex Rhode Island Corporation on December 07, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Immunex Rhode Island Corporation
- Inspection Date: 2021-12-07
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Immunex Rhode Island Corporation, a drug substance manufacturer in West Greenwich, Rhode Island, was cited for several deficiencies during an FDA inspection. Observations included a lack of procedural control for incoming material qualification, inadequate cleaning procedures, poorly maintained facility equipment, and insufficient standard operating procedures. These issues indicate a need for improved quality control and operational oversight.

## Related Documents

- [483 - 2019-04-19](https://www.globalkeysolutions.net/records/483/immunex-rhode-island-corporation/c17e7d1d-c8e1-4c34-a2c6-f51450079508)

## Related Officers

- [Lead  Biologist](https://www.globalkeysolutions.net/people/leiyun-w-boone/454ce531-ae82-4ae4-9b3d-8e4e8afed127)
- [Jacek Cieslak](https://www.globalkeysolutions.net/people/jacek-cieslak/81b12add-49f1-4dfd-bcb1-60bc5b212b68)
- [Richard Ledwidge](https://www.globalkeysolutions.net/people/richard-ledwidge/aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9)

Company: https://www.globalkeysolutions.net/companies/immunex-rhode-island-corporation/c70ebfcc-0c4d-4294-845a-24f1af8f30e9

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd