FDA Inspection
Maquet Cardiopulmonary Medical Teknik San. Tic. Ltd. Sti.Maquet Cardiopulmonary Medical Teknik San. Tic. Ltd. Sti. – FDA Inspection, Dec 17, 2013
Record Details
This FDA Inspection record concerns Maquet Cardiopulmonary Medical Teknik San. Tic. Ltd. Sti., with an inspection on December 17, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 17, 2013
- Product Type
- Devices
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ID · ba45808c-a20c-490e-9b24-e777556b4b6c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 859535
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.198(b)Rationale documented for no investigation
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