Bristol Myers Squibb Manufacturing
Form 483 issued November 18, 2016 · Humacao, Puerto Rico
- Inspection
- Nov 14 – Nov 18, 2016
- Investigator
- Noreen Muniz
- Observations
- 4
- Pages
- 6
- FEI number
- 2623458
In short: On November 18, 2016, FDA issued a Form 483 with 4 observations to Bristol Myers Squibb Manufacturing in Humacao, Puerto Rico (FEI 2623458) after an inspection that ran Nov 14 – Nov 18, 2016. The investigator was Noreen Muniz. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written production and process control procedures are not followed in the execution of production…
- 02
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment…
- 03
Batch production and control records are not prepared for each batch of drug product produced and…
- 04
Strict control is not exercised over labeling issued for use in…
This inspection in context
Noreen Muniz
24 documents · 2008–2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmBristol Myers Squibb Manufacturing history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bristol Myers Squibb Manufacturing?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Bristol Myers Squibb Manufacturing?
Noreen Muniz is named on this Form 483, for the inspection of Nov 14 – Nov 18, 2016. Each investigator has a profile showing what they cite most.
When was Bristol Myers Squibb Manufacturing inspected by FDA?
The inspection ran Nov 14 – Nov 18, 2016, and the Form 483 is dated November 18, 2016.
How do I get the full Form 483 for Bristol Myers Squibb Manufacturing?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.