Advanced Accelerator Applications (Italy) srl
Form 483 issued September 3, 2019 · Colleretto Giacosa, Italy
- Inspection
- Aug 26 – Sep 3, 2019
- Observations
- 4
- Pages
- 5
- FEI number
- 3010175147
In short: On September 3, 2019, FDA issued a Form 483 with 4 observations to Advanced Accelerator Applications (Italy) srl in Colleretto Giacosa, TO (FEI 3010175147) after an inspection that ran Aug 26 – Sep 3, 2019. Most observations concern production and materials.
At a glance
Production and materials account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
There was a failure to handle and store drug product containers and closures at all times…
- 03
Written procedures are not followed that describe the in-process controls and examinations to be conducted on…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Questions about this 483
What did FDA find at Advanced Accelerator Applications (Italy) srl?
FDA listed 4 observations on this Form 483, mostly about production, materials and laboratory controls. The opening words of each observation are shown on this page.
When was Advanced Accelerator Applications (Italy) srl inspected by FDA?
The inspection ran Aug 26 – Sep 3, 2019, and the Form 483 is dated September 3, 2019.
How do I get the full Form 483 for Advanced Accelerator Applications (Italy) srl?
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.