Acella Pharmaceuticals, LLC
Form 483 issued December 18, 2024 · Alpharetta, Georgia
- Inspection
- Dec 9 – Dec 18, 2024
- Observations
- 3
- Pages
- 5
- FEI number
- 3006691461
In short: On December 18, 2024, FDA issued a Form 483 with 3 observations to Acella Pharmaceuticals, LLC in Alpharetta, Georgia (FEI 3006691461) after an inspection that ran Dec 9 – Dec 18, 2024. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Not all annual periodic adverse drug experience reports have been submitted within 60 days of the…
- 02
Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the…
- 03
An annual report was not submitted each year and within 60 days of the anniversary date…
This inspection in context
Questions about this 483
What did FDA find at Acella Pharmaceuticals, LLC?
FDA listed 3 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.
When was Acella Pharmaceuticals, LLC inspected by FDA?
The inspection ran Dec 9 – Dec 18, 2024, and the Form 483 is dated December 18, 2024.
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.