Acella Pharmaceuticals, LLC
Form 483 issued March 29, 2019 · Alpharetta, Georgia
- Inspection
- Mar 25 – Mar 29, 2019
- Investigator
- Vanessa E. Coulter
- Observations
- 2
- Pages
- 3
- FEI number
- 3006691461
In short: On March 29, 2019, FDA issued a Form 483 with 2 observations to Acella Pharmaceuticals, LLC in Alpharetta, Georgia (FEI 3006691461) after an inspection that ran Mar 25 – Mar 29, 2019. The investigator was Vanessa E. Coulter. The most-cited regulation is 21 CFR 314.81 (other postmarketing reports).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An annual report was not submitted within 60 days of the anniversary date of U.S. approval…
- 02
Not all annual periodic adverse drug experience reports have been submitted within 60 days of the…
This inspection in context
Vanessa E. Coulter
1 document · 2019
Cites 314.80 (postmarketing reporting of adverse drug experiences) more than any other section. Most of their documents are for sites in Georgia.
The firmAcella Pharmaceuticals, LLC history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 314.81
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Acella Pharmaceuticals, LLC?
FDA listed 2 observations 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 Acella Pharmaceuticals, LLC?
Vanessa E. Coulter is named on this Form 483, for the inspection of Mar 25 – Mar 29, 2019. Each investigator has a profile showing what they cite most.
When was Acella Pharmaceuticals, LLC inspected by FDA?
The inspection ran Mar 25 – Mar 29, 2019, and the Form 483 is dated March 29, 2019.
How do I get the full Form 483 for Acella Pharmaceuticals, 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.