Bristol-Myers Squibb Company
FDA inspection history across 2 sites, 2001 to 2023
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2001: one warning letter; 2017: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2001One warning letter, at New York, New York.
- 2017One Form 483, at Devens, Massachusetts.
- 2023One Form 483, at Devens, Massachusetts.
- 2023The longest 483 on file: 1 observation over 2 pages at Devens, Massachusetts.
Cited most
Across all Bristol-Myers Squibb observations on file
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Bristol-Myers Squibb file.
All 3 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
Devens, Massachusetts
Two Form 483s · 2017 to 2023 · 2 observations
Latest: Form 483, May 5, 2023 →New York, New York
One warning letter · 2001
Latest: Warning letter, Aug 29, 2001 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-05-05 | 483 Form 483 | Devens, Massachusetts | 1 | $99 |
| 2017-04-05 | 483 Form 483 | Devens, Massachusetts | 1 | $99 |
| 2001-08-29 | Warning letter Warning letter | New York, New York | — | $99 |
Investigators on these documents
Erik W. Koester (1)Robert J. Martin (1)Sean R. Marcsisin (1)
FEI number 3008455069 · most recent document May 5, 2023
About Bristol-Myers Squibb Company
How many FDA Form 483s has Bristol-Myers Squibb Company received?
FDA Intel has 2 Form 483s on file for Bristol-Myers Squibb Company; the most recent is dated May 5, 2023.
When was Bristol-Myers Squibb Company last inspected by FDA?
The most recent FDA inspection document on file for Bristol-Myers Squibb Company is a Form 483 dated May 5, 2023, for the site in Devens, Massachusetts.
What did FDA cite at Bristol-Myers Squibb Company?
The regulations cited most in the observations on file for Bristol-Myers Squibb Company are 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 1 time.
Has Bristol-Myers Squibb Company received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Bristol-Myers Squibb Company; the most recent is dated Aug 29, 2001.