Appco Pharma, LLC
Form 483 issued April 15, 2019 · Somerset, New Jersey
- Inspection
- Apr 8 – Apr 15, 2019
- Investigator
- Nina Yang
- Observations
- 1
- Pages
- 3
- FEI number
- 3008793007
In short: On April 15, 2019, FDA issued a Form 483 with 1 observation to Appco Pharma, LLC in Somerset, New Jersey (FEI 3008793007) after an inspection that ran Apr 8 – Apr 15, 2019. The investigator was Nina Yang. 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 quarterly periodic adverse drug experience reports have been submitted within 30 days of the…
This inspection in context
Nina Yang
1 document · 2019
Cites 314.80(c)(2) (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
The site's inspection history, in date order.
Similar 483sOther sites cited under 314.80(c)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Appco Pharma, LLC?
FDA listed 1 observation 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?
Nina Yang is named on this Form 483, for the inspection of Apr 8 – Apr 15, 2019. Each investigator has a profile showing what they cite most.
When was Appco Pharma, LLC inspected by FDA?
The inspection ran Apr 8 – Apr 15, 2019, and the Form 483 is dated April 15, 2019.
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.