FDA Inspection
Bioptron AGBioptron AG – FDA Inspection, Nov 2, 2017
Record Details
This FDA Inspection record concerns Bioptron AG, with an inspection on November 2, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 80a182b3-4902-475d-89ab-9f6e19186d53
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031661
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 1002.10(d)Description of function, op. characteristics, uses
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.200(d)Service reports
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design validation - documentation
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