Appco Pharma LLC
Form 483 issued March 11, 2024 · Piscataway, New Jersey
- Inspection
- Mar 5 – Mar 11, 2024
- Investigator
- Tyanna N. Hadley
- Observations
- 2
- Pages
- 3
- FEI number
- 3010014758
In short: On March 11, 2024, FDA issued a Form 483 with 2 observations to Appco Pharma LLC in Piscataway, New Jersey (FEI 3010014758) after an inspection that ran Mar 5 – Mar 11, 2024. The investigator was Tyanna N. Hadley. 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
Adverse drug experiences that were the subject of post marketing 15-day…
- 02
Written procedures have not been developed for the surveillance, receipt and evaluation of post…
This inspection in context
Tyanna N. Hadley
3 documents · 2022–2024
Cites 314.80(b) (postmarketing reporting of adverse drug experiences) more than any other section. Most of their documents are for sites in New Jersey.
The firmAppco Pharma LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 314.80(c)(1)(ii)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Appco Pharma LLC?
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 Appco Pharma LLC?
Tyanna N. Hadley is named on this Form 483, for the inspection of Mar 5 – Mar 11, 2024. Each investigator has a profile showing what they cite most.
When was Appco Pharma LLC inspected by FDA?
The inspection ran Mar 5 – Mar 11, 2024, and the Form 483 is dated March 11, 2024.
How do I get the full Form 483 for Appco Pharma LLC?
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.