Indena SpA
Form 483 issued July 29, 2016 · Milano, Italy
- Inspection
- Jul 25 – Jul 29, 2016
- Investigators
- June Pak· Sangeeta M. Khurana
- Observations
- 1
- Pages
- 2
- FEI number
- 1000280888
In short: On July 29, 2016, FDA issued a Form 483 with 1 observation to Indena SpA in Milano, Milano (FEI 1000280888) after an inspection that ran Jul 25 – Jul 29, 2016. The investigators were June Pak and Sangeeta M. Khurana. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your Production/QC department failed to perform adequate investigation and root cause analysis for the observed repeated…
This inspection in context
June Pak
1 document · 2016
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Italy.
The firmIndena SpA history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Indena SpA?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Indena SpA?
June Pak and Sangeeta M. Khurana are named on this Form 483, for the inspection of Jul 25 – Jul 29, 2016. Each investigator has a profile showing what they cite most.
When was Indena SpA inspected by FDA?
The inspection ran Jul 25 – Jul 29, 2016, and the Form 483 is dated July 29, 2016.
How do I get the full Form 483 for Indena 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.