Procos SpA
Form 483 issued February 26, 2016 · Cameri, Italy
- Inspection
- Feb 22 – Feb 26, 2016
- Investigator
- Tamil Arasu
- Observations
- 1
- Pages
- 2
- FEI number
- 3002807938
In short: On February 26, 2016, FDA issued a Form 483 with 1 observation to Procos SpA in Cameri, Novara (FEI 3002807938) after an inspection that ran Feb 22 – Feb 26, 2016. The investigator was Tamil Arasu. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×) · 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Computerized systems lack sufficient controls to prevent unauthorized access…
This inspection in context
Tamil Arasu
27 documents · 2011–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmProcos SpA history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Procos SpA?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Procos SpA?
Tamil Arasu is named on this Form 483, for the inspection of Feb 22 – Feb 26, 2016. Each investigator has a profile showing what they cite most.
When was Procos SpA inspected by FDA?
The inspection ran Feb 22 – Feb 26, 2016, and the Form 483 is dated February 26, 2016.
How do I get the full Form 483 for Procos 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.