FDA Inspection
BEMA-GMBH & CO. KGBEMA-GMBH & CO. KG – FDA Inspection, Jul 19, 2018
Record Details
This FDA Inspection record concerns BEMA-GMBH & CO. KG, with an inspection on July 19, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- James W. Whitney (Issuing Officer)
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ID · d6c7b6db-ecd6-4a18-9711-5e52bc83aa11
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1059835
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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