Company
GermanyGAMBRO ROSTOCK GMBH, Rostock, Germany – FDA Inspections
Inspection records and compliance data for GAMBRO ROSTOCK GMBH in Rostock. 1 FDA inspection on record, 1 Form 483, last inspected July 06, 2017.
Company Profile
This profile covers GAMBRO ROSTOCK GMBH based in Rostock, Germany.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected July 6, 2017.
Most cited issue areas
- Design validation - Risk analysis1 inspection
- Lack of or inadequate process validation1 inspection
- Statistical techniques - Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 6, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1016943 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
GAMBRO ROSTOCK GMBH
FEI Number
3007697864
Address
Friedrich-Barnewitz-Str. 3, Rostock, Germany
Country
Germany
ID: 7632ac20-f238-4e1a-b68a-a0afc62b0d4f