Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company
Form 483 issued November 19, 2019 · Manati, Puerto Rico
- Inspection
- Nov 4 – Nov 19, 2019
- Investigator
- Libia M. Lugo
- Observations
- 5
- Pages
- 5
- FEI number
- 2650089
In short: On November 19, 2019, FDA issued a Form 483 with 5 observations to Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company in Manati, Puerto Rico (FEI 2650089) after an inspection that ran Nov 4 – Nov 19, 2019. The investigator was Libia M. Lugo. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Laboratory records are deficient in that they do not include a complete record of all…
- 03
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 04
Buildings used in the manufacture, processing, packing or holding of drug products are not free of…
This inspection in context
Libia M. Lugo
24 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmBristol-Myers Squibb Holdings Pharma Ltd. Liability Company history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company?
FDA listed 5 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company?
Libia M. Lugo is named on this Form 483, for the inspection of Nov 4 – Nov 19, 2019. Each investigator has a profile showing what they cite most.
When was Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company inspected by FDA?
The inspection ran Nov 4 – Nov 19, 2019, and the Form 483 is dated November 19, 2019.
How do I get the full Form 483 for Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company?
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.