# FDA 483 - Immunex Rhode Island Corporation - April 19, 2019

Source: https://www.keypedia.com/records/483/immunex-rhode-island-corporation/c17e7d1d-c8e1-4c34-a2c6-f51450079508

> FDA 483 for Immunex Rhode Island Corporation on April 19, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Immunex Rhode Island Corporation
- Inspection Date: 2019-04-19
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Immunex Rhode Island Corporation (Amgen Rhode Island) in West Greenwich, RI, a drug substance manufacturer, identified four significant observations. These included inadequate procedures for investigating out-of-specification results, insufficient Quality Unit oversight of instrument calibration and maintenance, and failures in conducting adequate deviation investigations. Additionally, the Quality Unit lacked proper oversight over critical manufacturing steps, allowing unauthorized changes to parameters.

## Related Documents

- [483 - 2021-12-07](https://www.keypedia.com/records/483/immunex-rhode-island-corporation/120e9273-7a08-4e38-914b-201969361429)

## Related Officers

- [Ziyang Su, PhD, Chemist](https://www.keypedia.com/people/ziyang-su-phd-chemist/2cad66e6-b0e4-4bf4-b13e-2073e9773eb6)
- [Lei Zhang, PhD, Staff Fellow](https://www.keypedia.com/people/lei-zhang-phd-staff-fellow/8e49cf85-7c1b-40ea-ac7b-2bc522dd050a)
- [Yetao Jin, PhD, Lead Chemist](https://www.keypedia.com/people/yetao-jin-phd-lead-chemist/94d80045-060e-4a04-b529-9dc13ff8e7db)
- [William Hallett, PhD, Biologist](https://www.keypedia.com/people/william-hallett-phd-biologist/c526ee40-5bce-46a7-b1f1-0270abda9d59)
- [Zhihao Peter Qiu, PhD, Supervisory Consumer Safety Officer](https://www.keypedia.com/people/zhihao-peter-qiu-phd-supervisory-consumer-safety-officer/ed209356-c2b6-4b0e-a8e4-8558cccfc9a3)

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

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