FDA Inspection
Immuno-Mycologics, IncImmuno-Mycologics, Inc – FDA Inspection, Jul 14, 2023
Record Details
This FDA Inspection record concerns Immuno-Mycologics, Inc, with an inspection on July 14, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ddd25afd-d07f-4117-8be8-c14487718b51
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210102
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Immuno-Mycologics, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 5, 2026 | VAI | Dallas District Office | Compliance: Medical Devices |
| March 18, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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