Pierre Fabre Pharmaceuticals, Inc
Form 483 issued November 1, 2024 · Parsippany, New Jersey
- Inspection
- Oct 28 – Nov 1, 2024
- Investigator
- Meredith L. Miller
- Observations
- 2
- Pages
- 3
- FEI number
- 3013144400
In short: On November 1, 2024, FDA issued a Form 483 with 2 observations to Pierre Fabre Pharmaceuticals, Inc in Parsippany, New Jersey (FEI 3013144400) after an inspection that ran Oct 28 – Nov 1, 2024. The investigator was Meredith L. Miller. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
What FDA observed
Preview: the opening words of each observation- 01
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA…
- 02
You submitted an ICSR reporting initial reporter information that failed to include the name, address, telephone…
This inspection in context
Meredith L. Miller
1 document · 2024
Cites 314.80(c)(1)(i) (postmarketing reporting of adverse drug experiences) more than any other section. Most of their documents are for sites in New Jersey.
The firmPierre Fabre Pharmaceuticals, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 314.80(c)(1)(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pierre Fabre Pharmaceuticals, Inc?
FDA listed 2 observations on this Form 483. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
Who inspected Pierre Fabre Pharmaceuticals, Inc?
Meredith L. Miller is named on this Form 483, for the inspection of Oct 28 – Nov 1, 2024. Each investigator has a profile showing what they cite most.
When was Pierre Fabre Pharmaceuticals, Inc inspected by FDA?
The inspection ran Oct 28 – Nov 1, 2024, and the Form 483 is dated November 1, 2024.
How do I get the full Form 483 for Pierre Fabre 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.