Acella Pharmaceuticals, LLC
Form 483 issued February 10, 2023 · Alpharetta, Georgia
- Inspection
- Jan 24 – Feb 10, 2023
- Investigators
- Jessica M. Simpson· Veronica Fuentes
- Observations
- 4
- Pages
- 5
- FEI number
- 3006691461
In short: On February 10, 2023, FDA issued a Form 483 with 4 observations to Acella Pharmaceuticals, LLC in Alpharetta, Georgia (FEI 3006691461) after an inspection that ran Jan 24 – Feb 10, 2023. The investigators were Jessica M. Simpson and Veronica Fuentes. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
3 of 4 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 responsibility to approve and reject all procedures or specifications impacting on…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has…
- 04
Procedures describing the handling of all written and oral complaints regarding a drug…
This inspection in context
Jessica M. Simpson
4 documents · 2022–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
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 4 observations on this Form 483, mostly about quality system and laboratory controls. 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?
Jessica M. Simpson and Veronica Fuentes are named on this Form 483, for the inspection of Jan 24 – Feb 10, 2023. Each investigator has a profile showing what they cite most.
When was Acella Pharmaceuticals, LLC inspected by FDA?
The inspection ran Jan 24 – Feb 10, 2023, and the Form 483 is dated February 10, 2023.
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.