Advanced Accelerator Applications USA, Inc.
Form 483 issued June 27, 2024 · Millburn, New Jersey
- Inspection
- Jun 18 – Jun 27, 2024
- Investigator
- Adetutu Gidado
- Observations
- 3
- Pages
- 4
- FEI number
- 3012484129
In short: On June 27, 2024, FDA issued a Form 483 with 3 observations to Advanced Accelerator Applications USA, Inc. in Millburn, New Jersey (FEI 3012484129) after an inspection that ran Jun 18 – Jun 27, 2024. The investigator was Adetutu Gidado. Most observations concern materials and laboratory controls.
At a glance
Materials and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 02
Laboratory records do not include complete records of any testing and standardization…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Adetutu Gidado
16 documents · 2016–2025
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The firmAdvanced Accelerator Applications USA, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advanced Accelerator Applications USA, Inc.?
FDA listed 3 observations on this Form 483, mostly about materials, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Advanced Accelerator Applications USA, Inc.?
Adetutu Gidado is named on this Form 483, for the inspection of Jun 18 – Jun 27, 2024. Each investigator has a profile showing what they cite most.
When was Advanced Accelerator Applications USA, Inc. inspected by FDA?
The inspection ran Jun 18 – Jun 27, 2024, and the Form 483 is dated June 27, 2024.
How do I get the full Form 483 for Advanced Accelerator Applications USA, Inc.?
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.