Bristol Myers Squibb Manufacturing
FDA inspection history across 2 sites, 2002 to 2016
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2002: one warning letter; 2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2002One warning letter, at New York, New York.
- 2016One Form 483, at Humacao, Puerto Rico.
Cited most
Across all Bristol Myers Squibb Manufacturing observations on file
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.125(a)Labeling issuance1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.67(b)Equipment cleaning and maintenance1
The complete Bristol Myers Squibb Manufacturing 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
Humacao, Puerto Rico
One Form 483 · 2016 · 4 observations
Latest: Form 483, Nov 18, 2016 →New York, New York
One warning letter · 2002
Latest: Warning letter, Oct 23, 2002 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-11-18 | 483 Form 483 | Humacao, Puerto Rico | 4 | $99 |
| 2002-10-23 | Warning letter Warning letter | New York, New York | — | $99 |
Investigators on these documents
FEI number 2623458 · most recent document Nov 18, 2016
About Bristol Myers Squibb Manufacturing
How many FDA Form 483s has Bristol Myers Squibb Manufacturing received?
FDA Intel has 1 Form 483 on file for Bristol Myers Squibb Manufacturing; the most recent is dated Nov 18, 2016.
When was Bristol Myers Squibb Manufacturing last inspected by FDA?
The most recent FDA inspection document on file for Bristol Myers Squibb Manufacturing is a Form 483 dated Nov 18, 2016, for the site in Humacao, Puerto Rico.
What did FDA cite at Bristol Myers Squibb Manufacturing?
The regulations cited most in the observations on file for Bristol Myers Squibb Manufacturing are 21 CFR 211.100(b) (Written procedures; deviations), 1 time; 21 CFR 211.125(a) (Labeling issuance), 1 time; 21 CFR 211.188 (Batch production and control records), 1 time.
Has Bristol Myers Squibb Manufacturing received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Bristol Myers Squibb Manufacturing; the most recent is dated Oct 23, 2002.