Cosma SpA
Form 483 issued January 15, 2016 · Ciserano, Italy
- Inspection
- Jan 11 – Jan 15, 2016
- Investigator
- Sandra A. Hughes
- Observations
- 6
- Pages
- 5
- FEI number
- 3002806754
In short: On January 15, 2016, FDA issued a Form 483 with 6 observations to Cosma SpA in Ciserano, Italy (FEI 3002806754) after an inspection that ran Jan 11 – Jan 15, 2016. The investigator was Sandra A. Hughes. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Facilities & equipment and laboratory controls account for 4 of 5 observations.
Most cited: 21 CFR 211.194 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to maintain complete data derived from all testing and to ensure compliance with established specifications…
- 03
The specifications for the two non-sterile APIs USP) intended to be used in further processing to…
- 04
Failure to maintain complete data derived from all testing and to ensure compliance with established API…
- 05
Quality was not performing…
This inspection in context
Sandra A. Hughes
23 documents · 2009–2019
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Wisconsin.
The firmCosma SpA history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cosma SpA?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Cosma SpA?
Sandra A. Hughes is named on this Form 483, for the inspection of Jan 11 – Jan 15, 2016. Each investigator has a profile showing what they cite most.
When was Cosma SpA inspected by FDA?
The inspection ran Jan 11 – Jan 15, 2016, and the Form 483 is dated January 15, 2016.
How do I get the full Form 483 for Cosma 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.