Form 483 · FEI 3042366712
Form 483 issued March 13, 2026 · Phoenix, Arizona
- Inspection
- Mar 9 – Mar 13, 2026
- Investigators
- Andra Lepnis· Lan T. Tran
- Observations
- 2
- Pages
- 5
- FEI number
- 3042366712
In short: On March 13, 2026, FDA issued a Form 483 with 2 observations to an FDA-inspected site in Phoenix, Arizona (FEI 3042366712) after an inspection that ran Mar 9 – Mar 13, 2026. The investigators were Andra Lepnis and Lan T. Tran. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.62 (investigator recordkeeping and record retention).
At a glance
2 of 2 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.62(b) (1×) · 312.60 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Failure to prepare or maintain adequate and accurate case histories with respect to observations and data…
- 02
An investigation was not conducted in accordance with the signed statement of investigator and investigational plan…
This inspection in context
Andra Lepnis
1 document · 2026
Cites 312.60 (general responsibilities of investigators) more than any other section. Most of their documents are for sites in Arizona.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 312.62(b)
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 312.62 (investigator recordkeeping and record retention). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Andra Lepnis and Lan T. Tran are named on this Form 483, for the inspection of Mar 9 – Mar 13, 2026. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Mar 9 – Mar 13, 2026, and the Form 483 is dated March 13, 2026.
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.