Company
GermanyRoche Pharma AG, Grenzach-Wyhlen, Germany – FDA Inspections
Inspection records and compliance data for Roche Pharma AG in Grenzach-Wyhlen. 3 FDA inspections on record, 1 Form 483, last inspected November 25, 2016.
Company Profile
This profile covers Roche Pharma AG based in Grenzach-Wyhlen, Germany.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected September 21, 2011. Last inspected November 25, 2016.
Most cited issue areas
- Following/documenting laboratory controls1 inspection
- Scientifically sound laboratory controls1 inspection
- Written record of complaint to include findings, follow-up1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 25, 2016 | VAI | Human Drugs · Drug Quality Assurance | 996367 |
| December 2, 2014 | VAI | Human Drugs · Drug Quality Assurance | 908975 |
| September 21, 2011 | VAI | Human Drugs · Drug Quality Assurance | 750829 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Roche Pharma AG
FEI Number
3002807206
Address
Emil-Barell-Str. 1, Grenzach-Wyhlen, Germany
Country
Germany
ID: 74803bfb-9fe8-4f1c-9819-be9f76c1860d