Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company
FDA inspection history in Manati, Puerto Rico, 2019 to 2026
- 3
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2021: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–21Two Form 483s, at Manati, Puerto Rico.
- 2021The longest 483 on file: 9 observations over 18 pages at Manati, Puerto Rico.
- 2026One Form 483, at Manati, Puerto Rico.
Cited most
Across all Bristol-Myers Squibb Holdings Pharma Ltd. Liability observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 8201
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160(b)General requirements1
The complete Bristol-Myers Squibb Holdings Pharma Ltd. Liability 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
Manati, Puerto Rico
Three Form 483s · 2019 to 2026 · 17 observations
Latest: Form 483, Feb 13, 2026 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-02-13 | 483 Form 483 | Manati, Puerto Rico | 3 | $99 |
| 2021-07-12 | 483 Form 483 | Manati, Puerto Rico | 9 | $99 |
| 2019-11-19 | 483 Form 483 | Manati, Puerto Rico | 5 | $99 |
Investigators on these documents
Adaliz Santaliz-Cruz (1)Angelica M. Hernandez (1)Libia M. Lugo (1)Santos E. Camara (1)
FEI number 2650089 · most recent document Feb 13, 2026
About Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company
How many FDA Form 483s has Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company received?
FDA Intel has 3 Form 483s on file for Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; the most recent is dated Feb 13, 2026.
When was Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company last inspected by FDA?
The most recent FDA inspection document on file for Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company is a Form 483 dated Feb 13, 2026, for the site in Manati, Puerto Rico.
What did FDA cite at Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company?
The regulations cited most in the observations on file for Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.22 (Responsibilities of quality control unit), 3 times; 21 CFR 820, 1 time.