FDA Inspection
RM Temena GmbHRM Temena GmbH – FDA Inspection, Feb 27, 2014
Record Details
This FDA Inspection record concerns RM Temena GmbH, with an inspection on February 27, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- RM Temena GmbH
- Inspection Date
- February 27, 2014
- Product Type
- Devices
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ID · f1313d8f-70c6-41fb-aa36-4b2241d82601
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 871224
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
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