Form 483 · FEI 3033061128
Form 483 issued February 28, 2025
- Observations
- 2
- Pages
- 3
- FEI number
- 3033061128
In short: On February 28, 2025, FDA issued a Form 483 with 2 observations to an FDA-inspected site (FEI 3033061128). Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.68 (inspection of investigator's records and reports).
At a glance
2 of 2 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.68 (1×) · 312.64(b) (1×)
What FDA observed
Preview: the opening words of each observation- 0121 CFR 312.68
Failure to permit an authorized officer or employee of FDA to have access to and…
- 02
Failure to report serious adverse events…
This inspection in context
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 2 observations on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.68 (inspection of investigator's records and reports). The opening words of each observation are shown on this page.
When was an FDA-inspected site inspected by FDA?
This Form 483 is dated February 28, 2025.
How do I get the full Form 483 for an FDA-inspected site?
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.