Amici Pharma Inc
Form 483 issued November 12, 2024 · Melville, New York
- Inspection
- Nov 6 – Nov 12, 2024
- Investigator
- Omadevi Somai
- Observations
- 1
- Pages
- 2
- FEI number
- 3014357169
In short: On November 12, 2024, FDA issued a Form 483 with 1 observation to Amici Pharma Inc in Melville, New York (FEI 3014357169) after an inspection that ran Nov 6 – Nov 12, 2024. The investigator was Omadevi Somai. The most-cited regulation is 21 CFR 314.81 (other postmarketing reports).
What FDA observed
Preview: the opening words of each observation- 01
An annual report was not submitted within 60 days of the anniversary date of U.S. approval…
This inspection in context
Omadevi Somai
2 documents · 2019–2024
Cites 314.80(b) (postmarketing reporting of adverse drug experiences) more than any other section. Most of their documents are for sites in New York.
The firmAmici Pharma Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 314.81(b)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amici Pharma Inc?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 314.81 (other postmarketing reports). The opening words of each observation are shown on this page.
Who inspected Amici Pharma Inc?
Omadevi Somai is named on this Form 483, for the inspection of Nov 6 – Nov 12, 2024. Each investigator has a profile showing what they cite most.
When was Amici Pharma Inc inspected by FDA?
The inspection ran Nov 6 – Nov 12, 2024, and the Form 483 is dated November 12, 2024.
How do I get the full Form 483 for Amici Pharma 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.