BRACCO IMAGING SPA
Form 483 issued April 12, 2022 · COLLERETTO GIACOSA, Italy
- Inspection
- Apr 4 – Apr 12, 2022
- Investigator
- Yasamin Ameri
- Observations
- 3
- Pages
- 2
- FEI number
- 3005604782
In short: On April 12, 2022, FDA issued a Form 483 with 3 observations to BRACCO IMAGING SPA in COLLERETTO GIACOSA, Italy (FEI 3005604782) after an inspection that ran Apr 4 – Apr 12, 2022. The investigator was Yasamin Ameri. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment 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
Written production and process control procedures are not followed in the execution of production…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Employees engaged in the manufacture, processing and holding of a drug product lack the traming required…
This inspection in context
Yasamin Ameri
20 documents · 2015–2022
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in India.
The firmBRACCO IMAGING SPA history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BRACCO IMAGING SPA?
FDA listed 3 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected BRACCO IMAGING SPA?
Yasamin Ameri is named on this Form 483, for the inspection of Apr 4 – Apr 12, 2022. Each investigator has a profile showing what they cite most.
When was BRACCO IMAGING SPA inspected by FDA?
The inspection ran Apr 4 – Apr 12, 2022, and the Form 483 is dated April 12, 2022.
How do I get the full Form 483 for BRACCO IMAGING SPA?
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.