FDA Inspection
HUMANOPTICS HOLDING AGHUMANOPTICS HOLDING AG – FDA Inspection, Apr 19, 2018
Record Details
This FDA Inspection record concerns HUMANOPTICS HOLDING AG, with an inspection on April 19, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e407b33b-9f99-41ac-b493-13d102db0a63
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1050300
- 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 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of HUMANOPTICS HOLDING AG
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 27, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for HUMANOPTICS HOLDING AG
- FDA Inspection 1253721 - 2024-06-27
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