Acella Pharmaceuticals, LLC
Form 483 issued September 17, 2021 · Alpharetta, Georgia
- Inspection
- Aug 30 – Sep 17, 2021
- Investigators
- Song Y. Lavalais· Veronica Fuentes
- Observations
- 5
- Pages
- 7
- FEI number
- 3006691461
In short: On September 17, 2021, FDA issued a Form 483 with 5 observations to Acella Pharmaceuticals, LLC in Alpharetta, Georgia (FEI 3006691461) after an inspection that ran Aug 30 – Sep 17, 2021. The investigators were Song Y. Lavalais and Veronica Fuentes. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
4 of 5 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks the responsibility and authority to approve and reject all components, drug…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Procedures describing the handling of all written and oral complaints regarding a drug…
- 04
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education…
This inspection in context
Song Y. Lavalais
5 documents · 2021–2023
Cites 211.113 (control of microbiological contamination) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Acella Pharmaceuticals, LLC?
FDA listed 5 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Acella Pharmaceuticals, LLC?
Song Y. Lavalais and Veronica Fuentes are named on this Form 483, for the inspection of Aug 30 – Sep 17, 2021. Each investigator has a profile showing what they cite most.
When was Acella Pharmaceuticals, LLC inspected by FDA?
The inspection ran Aug 30 – Sep 17, 2021, and the Form 483 is dated September 17, 2021.
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.