Company
SwitzerlandSintetica S.A., Mendrisio, Switzerland – FDA Inspections
Inspection records and compliance data for Sintetica S.A. in Mendrisio. 6 FDA inspections on record, 2 Form 483s, last inspected November 09, 2023.
Company Profile
This profile covers Sintetica S.A. based in Mendrisio, Switzerland.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 5
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected October 28, 2010. Last inspected November 9, 2023.
Most cited issue areas
- Scientifically sound laboratory controls2 inspections
- Procedures for sterile drug products1 inspection
- Protection from external factors1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 9, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1244013 |
| May 17, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1095637 |
| December 6, 2016 | VAI | Human Drugs · Drug Quality Assurance | 1002397 |
| November 21, 2014 | VAI | Human Drugs · Drug Quality Assurance | 907553 |
| November 9, 2012 | NAI | Human Drugs · Drug Quality Assurance | 807676 |
| October 28, 2010 | VAI | Human Drugs · Drug Quality Assurance | 697847 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sintetica S.A.
FEI Number
3004058163
Address
Via Penate 5, Mendrisio, Switzerland
Country
Switzerland
ID: 74513e9a-830d-4af7-bbaa-01a8a33e81b5