Italfarmaco S.A.
Form 483 issued September 15, 2023 · Alcobendas, Spain
- Inspection
- Sep 11 – Sep 15, 2023
- Investigator
- Samir C. Gala
- Observations
- 1
- Pages
- 2
- FEI number
- 3007048260
In short: On September 15, 2023, FDA issued a Form 483 with 1 observation to Italfarmaco S.A. in Alcobendas, Madrid (FEI 3007048260) after an inspection that ran Sep 11 – Sep 15, 2023. The investigator was Samir C. Gala. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 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
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Samir C. Gala
10 documents · 2020–2024
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Connecticut.
The firmItalfarmaco S.A. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Italfarmaco S.A.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Italfarmaco S.A.?
Samir C. Gala is named on this Form 483, for the inspection of Sep 11 – Sep 15, 2023. Each investigator has a profile showing what they cite most.
When was Italfarmaco S.A. inspected by FDA?
The inspection ran Sep 11 – Sep 15, 2023, and the Form 483 is dated September 15, 2023.
How do I get the full Form 483 for Italfarmaco S.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.