Catalent Anagni S.R.L.
Form 483 issued July 16, 2024 · ANAGNI, Italy
- Inspection
- Jul 9 – Jul 16, 2024
- Investigators
- Ekaterina Allen· Scenes Ekaterina Allen
- Observations
- 6
- Pages
- 7
- FEI number
- 3002806546
In short: On July 16, 2024, FDA issued a Form 483 with 6 observations to Catalent Anagni S.R.L. in ANAGNI, Frosinone (FEI 3002806546) after an inspection that ran Jul 9 – Jul 16, 2024. The investigators were Ekaterina Allen and Scenes Ekaterina Allen. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
4 of 6 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug product purporting to be sterile are not…
- 02
Aseptic processing areas are inadequate regarding the system…
- 03
Qualification of visual inspection procedures designed to assure batches of injectable products meet appropriate specifications…
- 04
Procedures and validation for the cleaning and maintenance Mom nd equipment…
This inspection in context
Ekaterina Allen
6 documents · 2021–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Italy.
The firmCatalent Anagni S.R.L. 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 Catalent Anagni S.R.L.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment and production. 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 Catalent Anagni S.R.L.?
Ekaterina Allen and Scenes Ekaterina Allen are named on this Form 483, for the inspection of Jul 9 – Jul 16, 2024. Each investigator has a profile showing what they cite most.
When was Catalent Anagni S.R.L. inspected by FDA?
The inspection ran Jul 9 – Jul 16, 2024, and the Form 483 is dated July 16, 2024.
How do I get the full Form 483 for Catalent Anagni S.R.L.?
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.