FDA Inspection
MycoScience Labs, LLCMycoScience Labs, LLC – FDA Inspection, Feb 15, 2024
Record Details
This FDA Inspection record concerns MycoScience Labs, LLC, with an inspection on February 15, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f3328a79-6d9d-4785-8186-f7694de197ec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1230344
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MycoScience Labs, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 11, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 25, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 24, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 21, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for MycoScience Labs, LLC
- FDA Inspection 1234863 - 2025-01-16
- FDA Inspection 1094610 - 2019-06-11
- FDA Inspection 1022864 - 2017-08-25
- FDA Inspection 919150 - 2015-03-24
- FDA Inspection 819591 - 2013-02-21
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