Company
GermanyMaquet Cardiopulmonary GmbH, Hechingen, Germany – FDA Inspections
Inspection records and compliance data for Maquet Cardiopulmonary GmbH in Hechingen. 3 FDA inspections on record (3 OAI), last inspected June 24, 2022.
Company Profile
This profile covers Maquet Cardiopulmonary GmbH based in Hechingen, Germany.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 3
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected August 15, 2013. Last inspected June 24, 2022.
Most cited issue areas
- Design review - documentation1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 24, 2022 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1174429 |
| September 23, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 857077 |
| August 15, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 857072 |
FDA documents
Form 483s (1)
People (1)
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Maquet Cardiopulmonary GmbH
FEI Number
3009649876
Address
Neue Rottenburger Str. 37, Hechingen, Germany
Country
Germany
ID: 21b3de69-3682-4f19-8aec-1cfee4b55c0a