FDA Inspection
Anigan, Inc.Anigan, Inc. – FDA Inspection, May 23, 2019
Record Details
This FDA Inspection record concerns Anigan, Inc., with an inspection on May 23, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a469390e-1192-467e-a939-0c655308512f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1091122
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 820.30(f)Design verification - documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Anigan, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 31, 2019 | Not classified | San Francisco District Office | |
| April 19, 2018 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Anigan, Inc.
- FDA Inspection 1080171 - 2019-01-31
- FDA Inspection 1048839 - 2018-04-19
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