FDA Inspection
Immuno-Mycologics, IncImmuno-Mycologics, Inc – FDA Inspection, Mar 5, 2026
Record Details
This FDA Inspection record concerns Immuno-Mycologics, Inc, with an inspection on March 5, 2026, issued by the Dallas District Office, covering medical devices & rad health.
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ID · 18d6b217-8fd5-4cf5-841f-b7081d92a4e5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1305610
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
2- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.3.9Requirements for design and development changes not met before implementation
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Other FDA inspections of Immuno-Mycologics, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 18, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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