Bristol-Myers Squibb Company
Form 483 issued April 5, 2017 · Devens, Massachusetts
- Inspection
- Mar 16 – Apr 5, 2017
- Investigators
- Erik W. Koester· Robert J. Martin· Sean R. Marcsisin
- Observations
- 1
- Pages
- 1
- FEI number
- 3008455069
In short: On April 5, 2017, FDA issued a Form 483 with 1 observation to Bristol-Myers Squibb Company in Devens, Massachusetts (FEI 3008455069) after an inspection that ran Mar 16 – Apr 5, 2017. The investigators were Erik W. Koester, Robert J. Martin and Sean R. Marcsisin. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm’s vendor qualification program is inadequate in that the Quality Unit failed to establish the…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
The firmBristol-Myers Squibb 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 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bristol-Myers Squibb Company?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Bristol-Myers Squibb Company?
Erik W. Koester, Robert J. Martin and Sean R. Marcsisin are named on this Form 483, for the inspection of Mar 16 – Apr 5, 2017. Each investigator has a profile showing what they cite most.
When was Bristol-Myers Squibb Company inspected by FDA?
The inspection ran Mar 16 – Apr 5, 2017, and the Form 483 is dated April 5, 2017.
How do I get the full Form 483 for Bristol-Myers Squibb 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.