Immunex Rhode Island Corporation
FDA inspection history in West Greenwich, Rhode Island, 2019 to 2021
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–21Two Form 483s, at West Greenwich, Rhode Island.
- 2021The longest 483 on file: 4 observations over 2 pages at West Greenwich, Rhode Island.
Cited most
Across all Immunex Rhode Island observations on file
- 21 CFR 211.160General requirements3
- 21 CFR 211.192Production record review2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Immunex Rhode Island file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
West Greenwich, Rhode Island
Two Form 483s · 2019 to 2021 · 8 observations
Latest: Form 483, Dec 7, 2021 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-12-07 | 483 Form 483 | West Greenwich, Rhode Island | 4 | $99 |
| 2019-04-19 | 483 Form 483 | West Greenwich, Rhode Island | 4 | $99 |
Investigators on these documents
Jacek Cieslak (1)Lei Zhang (1)Leiyun Boone (1)Richard Ledwidge (1)William Hallett (1)Yetao Jin (1)Zhihao Peter Qiu (1)Ziyang Su (1)
FEI number 3003359885 · most recent document Dec 7, 2021
About Immunex Rhode Island Corporation
How many FDA Form 483s has Immunex Rhode Island Corporation received?
FDA Intel has 2 Form 483s on file for Immunex Rhode Island Corporation; the most recent is dated Dec 7, 2021.
When was Immunex Rhode Island Corporation last inspected by FDA?
The most recent FDA inspection document on file for Immunex Rhode Island Corporation is a Form 483 dated Dec 7, 2021, for the site in West Greenwich, Rhode Island.
What did FDA cite at Immunex Rhode Island Corporation?
The regulations cited most in the observations on file for Immunex Rhode Island Corporation are 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times.