Bristol-Myers Squibb Company
Form 483 issued May 5, 2023 · Devens, Massachusetts
- Inspection
- May 5, 2023
- Observations
- 1
- Pages
- 2
- FEI number
- 3008455069
In short: On May 5, 2023, FDA issued a Form 483 with 1 observation to Bristol-Myers Squibb Company in Devens, Massachusetts (FEI 3008455069) after an inspection that ran May 5, 2023. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality system failed to fully investigate all manufacturing…
This inspection in context
Questions about this 483
What did FDA find at Bristol-Myers Squibb Company?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Bristol-Myers Squibb Company inspected by FDA?
The inspection ran May 5, 2023, and the Form 483 is dated May 5, 2023.
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.