Form 483 · FEI 3009543806
Form 483 issued March 3, 2023 · North Miami Beach, Florida
- Inspection
- Feb 27 – Mar 3, 2023
- Investigator
- Angelica M. Chica
- Observations
- 2
- Pages
- 4
- FEI number
- 3009543806
In short: On March 3, 2023, FDA issued a Form 483 with 2 observations to an FDA-inspected site in North Miami Beach, Florida (FEI 3009543806) after an inspection that ran Feb 27 – Mar 3, 2023. The investigator was Angelica M. Chica. 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…
- 02
Failure to prepare or maintain accurate case histories with respect to observations and data…
This inspection in context
Angelica M. Chica
3 documents · 2023–2025
Cites 312.62(b) (investigator recordkeeping and record retention) more than any other section. Most of their documents are for sites in Florida.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 312.60
See how FDA wrote the same problem up elsewhere.
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?
Angelica M. Chica is named on this Form 483, for the inspection of Feb 27 – Mar 3, 2023. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Feb 27 – Mar 3, 2023, and the Form 483 is dated March 3, 2023.
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.