Avion Pharmaceuticals, LLC
Form 483 issued November 8, 2023 · Alpharetta, Georgia
- Inspection
- Oct 30 – Nov 8, 2023
- Investigator
- Susan O. Oladeji
- Observations
- 4
- Pages
- 5
- FEI number
- 3010577308
In short: On November 8, 2023, FDA issued a Form 483 with 4 observations to Avion Pharmaceuticals, LLC in Alpharetta, Georgia (FEI 3010577308) after an inspection that ran Oct 30 – Nov 8, 2023. The investigator was Susan O. Oladeji. Most observations concern quality system and production; 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
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Procedures describing the holding, testing and reprocessing of returned drug products are not…
This inspection in context
Susan O. Oladeji
15 documents · 2017–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Georgia.
The firmAvion Pharmaceuticals, LLC history
The site's inspection history, in date order.
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 Avion Pharmaceuticals, LLC?
FDA listed 4 observations on this Form 483, mostly about quality system and production. 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 Avion Pharmaceuticals, LLC?
Susan O. Oladeji is named on this Form 483, for the inspection of Oct 30 – Nov 8, 2023. Each investigator has a profile showing what they cite most.
When was Avion Pharmaceuticals, LLC inspected by FDA?
The inspection ran Oct 30 – Nov 8, 2023, and the Form 483 is dated November 8, 2023.
How do I get the full Form 483 for Avion 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.