FDA Inspection
Heidelberg Medical IncHeidelberg Medical Inc – FDA Inspection, Feb 24, 2017
Record Details
This FDA Inspection record concerns Heidelberg Medical Inc, with an inspection on February 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5d4f3b7b-84f6-4fc8-805e-3fe453d6de64
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012625
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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