FDA Inspection
Micropen TechnologiesMicropen Technologies – FDA Inspection, Nov 14, 2018
Record Details
This FDA Inspection record concerns Micropen Technologies, with an inspection on November 14, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 70a0c1b9-e42d-4ac9-8693-3f3586a6ecb9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071858
- 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 820.70(i)Software validation for automated processes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Micropen Technologies
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 24, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Micropen Technologies
- FDA Inspection 1224005 - 2023-11-14
- FDA Inspection 1153364 - 2021-09-24
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