FDA Inspection
Hoggan Scientific LLCHoggan Scientific LLC – FDA Inspection, Aug 19, 2026
Record Details
This FDA Inspection record concerns Hoggan Scientific LLC, with an inspection on August 19, 2026, issued by the Denver District Office, covering medical devices & rad health.
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ID · f713f80e-888b-4b5d-a6e6-f8d40cff098d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1331706
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 7.3.7Design and development validation not complete prior to release of product
- ISO 13485:2016 Clause 7.4.2Purchasing information lacks written agreement regarding notification of changes
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
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Other FDA inspections of Hoggan Scientific LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 30, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 29, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Hoggan Scientific LLC
- FDA Inspection 1181180 - 2022-09-30
- FDA Inspection 958607 - 2016-01-29
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