Lan Luo, M.D. Ocala Cardiovascular Research, 2801 Se
Form 483 issued September 16, 2025 · Ocala, Florida
- Inspection
- Sep 2 – Sep 16, 2025
- Investigator
- Chinyere A. Asanya
- Observations
- 4
- Pages
- 9
- FEI number
- 3038258929
In short: On September 16, 2025, FDA issued a Form 483 with 4 observations to Lan Luo, M.D. Ocala Cardiovascular Research, 2801 Se in Ocala, Florida (FEI 3038258929) after an inspection that ran Sep 2 – Sep 16, 2025. The investigator was Chinyere A. Asanya. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.62 (investigator recordkeeping and record retention).
At a glance
4 of 4 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.62 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An investigation was not conducted in accordance with the signed statement of…
- 02
Investigational drug disposition records are not adequate with respect to quantity…
- 03
Failure to report non-serious adverse events to the sponsor in accordance with the study…
- 04
Failure to prepare or maintain adequate and accurate case histories with respect to observations and data…
This inspection in context
Chinyere A. Asanya
1 document · 2025
Cites 312.62 (investigator recordkeeping and record retention) more than any other section. Most of their documents are for sites in Florida.
The firmLan Luo, M.D. Ocala Cardiovascular Research, 2801 Se history
The site's inspection history, in date order.
Similar 483sOther sites cited under 312.62
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lan Luo, M.D. Ocala Cardiovascular Research, 2801 Se?
FDA listed 4 observations on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.62 (investigator recordkeeping and record retention). The opening words of each observation are shown on this page.
Who inspected Lan Luo, M.D. Ocala Cardiovascular Research, 2801 Se?
Chinyere A. Asanya is named on this Form 483, for the inspection of Sep 2 – Sep 16, 2025. Each investigator has a profile showing what they cite most.
When was Lan Luo, M.D. Ocala Cardiovascular Research, 2801 Se inspected by FDA?
The inspection ran Sep 2 – Sep 16, 2025, and the Form 483 is dated September 16, 2025.
How do I get the full Form 483 for Lan Luo, M.D. Ocala Cardiovascular Research, 2801 Se?
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.