Company
ItalyMerck Serono S.p.A., Modugno, Italy – FDA Inspections
Inspection records and compliance data for Merck Serono S.p.A. in Modugno. 9 FDA inspections on record, 3 Form 483s, last inspected May 10, 2023.
Company Profile
This profile covers Merck Serono S.p.A. based in Modugno, Italy.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 0
- VAI
- 8
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected July 16, 2010. Last inspected May 10, 2023.
Most cited issue areas
- Procedures not in writing, fully followed3 inspections
- Actual vs. theoretical yields not determined2 inspections
- Acceptance of drug products1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 10, 2023 | Not classified | Human Drugs | 1222768 |
| March 17, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1215892 |
| May 31, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1091595 |
| June 22, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1118104 |
| May 25, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1053903 |
| May 10, 2016 | VAI | Human Drugs · Drug Quality Assurance | 980565 |
| July 1, 2014 | VAI | Human Drugs · Drug Quality Assurance | 891189 |
| September 25, 2012 | VAI | Human Drugs · Drug Quality Assurance | 802081 |
| July 16, 2010 | VAI | Human Drugs · Drug Quality Assurance | 679871 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Merck Serono S.p.A.
FEI Number
3003581732
Address
Loc. Frazione Zona Industriale, Via Delle Magnolie 15, Modugno, Italy
Country
Italy
ID: 052a4b09-0189-4f5c-bdcc-33182a7d3488