Evaric Pharmaceuticals Inc
Form 483 issued May 16, 2025 · HAUPPAUGE, New York
- Inspection
- Jul 2, 2021 – May 16, 2025
- Investigator
- Alan M. Barker
- Observations
- 2
- Pages
- 23
- FEI number
- 3013061208
In short: On May 16, 2025, FDA issued a Form 483 with 2 observations to Evaric Pharmaceuticals Inc in HAUPPAUGE, New York (FEI 3013061208) after an inspection that ran Jul 2, 2021 – May 16, 2025. The investigator was Alan M. Barker. 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 312.62 (1×) · 312.60 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigational drug disposition records are not adequate with respect to dates, quantity…
- 02
An investigation was not conducted in accordance…
This inspection in context
Alan M. Barker
10 documents · 2021–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Michigan.
The firmEvaric Pharmaceuticals Inc history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
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 Evaric Pharmaceuticals Inc?
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 Evaric Pharmaceuticals Inc?
Alan M. Barker is named on this Form 483, for the inspection of Jul 2, 2021 – May 16, 2025. Each investigator has a profile showing what they cite most.
When was Evaric Pharmaceuticals Inc inspected by FDA?
The inspection ran Jul 2, 2021 – May 16, 2025, and the Form 483 is dated May 16, 2025.
How do I get the full Form 483 for Evaric Pharmaceuticals Inc?
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.