Fidia Farmaceutici, S.p.A.
Form 483 issued November 10, 2016 · Abano Terme, Italy
- Inspection
- Nov 7 – Nov 10, 2016
- Investigator
- Christine E. Kelley
- Observations
- 1
- Pages
- 2
- FEI number
- 3002806986
In short: On November 10, 2016, FDA issued a Form 483 with 1 observation to Fidia Farmaceutici, S.p.A. in Abano Terme, Padova (FEI 3002806986) after an inspection that ran Nov 7 – Nov 10, 2016. The investigator was Christine E. Kelley. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.250 (statistical techniques).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.250(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process…
This inspection in context
Christine E. Kelley
1 document · 2016
Cites 820.250(a) (statistical techniques) more than any other section. Most of their documents are for sites in Italy.
The firmFidia Farmaceutici, S.p.A. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.250(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fidia Farmaceutici, S.p.A.?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.250 (statistical techniques). The opening words of each observation are shown on this page.
Who inspected Fidia Farmaceutici, S.p.A.?
Christine E. Kelley is named on this Form 483, for the inspection of Nov 7 – Nov 10, 2016. Each investigator has a profile showing what they cite most.
When was Fidia Farmaceutici, S.p.A. inspected by FDA?
The inspection ran Nov 7 – Nov 10, 2016, and the Form 483 is dated November 10, 2016.
How do I get the full Form 483 for Fidia Farmaceutici, S.p.A.?
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.