Actavis Italy Spa A Socio Unico
Form 483 issued March 15, 2019 · Nerviano, Italy
- Inspection
- Mar 4 – Mar 15, 2019
- Investigator
- Philip F. Istafanos
- Observations
- 6
- Pages
- 8
- FEI number
- 3001116953
In short: On March 15, 2019, FDA issued a Form 483 with 6 observations to Actavis Italy Spa A Socio Unico in Nerviano, Italy (FEI 3001116953) after an inspection that ran Mar 4 – Mar 15, 2019. The investigator was Philip F. Istafanos. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
The written stability testing…
This inspection in context
Philip F. Istafanos
13 documents · 2014–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Canada.
The firmActavis Italy Spa A Socio Unico history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Actavis Italy Spa A Socio Unico?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Actavis Italy Spa A Socio Unico?
Philip F. Istafanos is named on this Form 483, for the inspection of Mar 4 – Mar 15, 2019. Each investigator has a profile showing what they cite most.
When was Actavis Italy Spa A Socio Unico inspected by FDA?
The inspection ran Mar 4 – Mar 15, 2019, and the Form 483 is dated March 15, 2019.
How do I get the full Form 483 for Actavis Italy Spa A Socio Unico?
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.