Company
ItalyMerck Serono S.p.A., Guidonia Montecelio, Italy – FDA Inspections
Inspection records and compliance data for Merck Serono S.p.A. in Guidonia Montecelio. 7 FDA inspections on record (1 OAI), last inspected July 11, 2024.
Company Profile
This profile covers Merck Serono S.p.A. based in Guidonia Montecelio, Italy.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 1
- VAI
- 2
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected April 30, 2009. Last inspected July 11, 2024.
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 11, 2024 | Not classified | Human Drugs | 1276476 |
| March 29, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1159215 |
| July 28, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1024129 |
| February 20, 2015 | NAI | Human Drugs · Drug Quality Assurance | 917646 |
| March 14, 2013 | VAI | Human Drugs · Drug Quality Assurance | 824763 |
| July 1, 2011 | OAI | Human Drugs · Drug Quality Assurance | 733934 |
| April 30, 2009 | NAI | Human Drugs · Drug Quality Assurance | 611311 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Merck Serono S.p.A.
FEI Number
3002807252
Address
Via Luigi Einaudi 11, Guidonia Montecelio, Italy
Country
Italy
ID: 8fa9cb7d-2f83-44d4-a712-34041b2933ff