Form 483 · FEI 3009256939
Form 483 issued June 17, 2022 · Vict oria
- Inspection
- Jun 6 – Jun 17, 2022
- Investigator
- Sherri N. Rohlf
- Observations
- 2
- Pages
- 5
- FEI number
- 3009256939
In short: On June 17, 2022, FDA issued a Form 483 with 2 observations to an FDA-inspected site in Vict oria (FEI 3009256939) after an inspection that ran Jun 6 – Jun 17, 2022. The investigator was Sherri N. Rohlf. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.60 (general responsibilities of investigators).
At a glance
2 of 2 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.60 (1×) · 312.62(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
An investigation was not conducted in accordance with the signed statement of…
- 02
Failure to prepare or maintain adequate case histories with respect to observations and data…
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 312.60 (general responsibilities of investigators). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Sherri N. Rohlf is named on this Form 483, for the inspection of Jun 6 – Jun 17, 2022. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jun 6 – Jun 17, 2022, and the Form 483 is dated June 17, 2022.
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.