Advanced Accelerator Applications USA, Inc.
Form 483 issued November 9, 2021 · Millburn, New Jersey
- Inspection
- Oct 20 – Nov 9, 2021
- Investigators
- Robin P. Mathew· Unnee Ranjan
- Observations
- 7
- Pages
- 8
- FEI number
- 3012484129
In short: On November 9, 2021, FDA issued a Form 483 with 7 observations to Advanced Accelerator Applications USA, Inc. in Millburn, New Jersey (FEI 3012484129) after an inspection that ran Oct 20 – Nov 9, 2021. The investigators were Robin P. Mathew and Unnee Ranjan. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 04
Equipment surfaces that contact drug products are reactive, additive or absorptive so as to alter the…
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 211.22
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 7 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Advanced Accelerator Applications USA, Inc.?
Robin P. Mathew and Unnee Ranjan are named on this Form 483, for the inspection of Oct 20 – Nov 9, 2021. Each investigator has a profile showing what they cite most.
When was Advanced Accelerator Applications USA, Inc. inspected by FDA?
The inspection ran Oct 20 – Nov 9, 2021, and the Form 483 is dated November 9, 2021.
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.