Advanced Accelerator Applications USA, Inc.
Form 483 issued November 3, 2022 · Millburn, New Jersey
- Inspection
- Oct 24 – Nov 3, 2022
- Investigator
- Robin P. Mathew
- Observations
- 5
- Pages
- 6
- FEI number
- 3012484129
In short: On November 3, 2022, FDA issued a Form 483 with 5 observations to Advanced Accelerator Applications USA, Inc. in Millburn, New Jersey (FEI 3012484129) after an inspection that ran Oct 24 – Nov 3, 2022. The investigator was Robin P. Mathew. Most observations concern production and quality system.
At a glance
Production and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Routine calibration, inspection and checking (His and(O@s equipment is not performed according to a written program…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Robin P. Mathew
11 documents · 2020–2025
Cites 211.192 (production record review) 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 211.100(a)
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 5 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Advanced Accelerator Applications USA, Inc.?
Robin P. Mathew is named on this Form 483, for the inspection of Oct 24 – Nov 3, 2022. Each investigator has a profile showing what they cite most.
When was Advanced Accelerator Applications USA, Inc. inspected by FDA?
The inspection ran Oct 24 – Nov 3, 2022, and the Form 483 is dated November 3, 2022.
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.