Kedrion S.p.A.
Form 483 issued June 24, 2022 · Lucca, Italy
- Inspection
- Jun 16 – Jun 24, 2022
- Investigator
- Lewis K. Antwi
- Observations
- 3
- Pages
- 4
- FEI number
- 3008919567
In short: On June 24, 2022, FDA issued a Form 483 with 3 observations to Kedrion S.p.A. in Lucca, Italy (FEI 3008919567) after an inspection that ran Jun 16 – Jun 24, 2022. The investigator was Lewis K. Antwi. Most observations concern facilities & equipment and production.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 02
Routine inspection and checking of mechanical equipment is not performed according to a written program designed…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Lewis K. Antwi
11 documents · 2019–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmKedrion S.p.A. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kedrion S.p.A.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Kedrion S.p.A.?
Lewis K. Antwi is named on this Form 483, for the inspection of Jun 16 – Jun 24, 2022. Each investigator has a profile showing what they cite most.
When was Kedrion S.p.A. inspected by FDA?
The inspection ran Jun 16 – Jun 24, 2022, and the Form 483 is dated June 24, 2022.
How do I get the full Form 483 for Kedrion 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.