FDA Inspection
MycoScience Labs, LLCMycoScience Labs, LLC – FDA Inspection, Aug 25, 2017
Record Details
This FDA Inspection record concerns MycoScience Labs, LLC, with an inspection on August 25, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · ed3a90a9-29ae-4e25-8560-71bef3cabc1e
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1022864
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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 |
| February 15, 2024 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 11, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| 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 1230344 - 2024-02-15
- FDA Inspection 1094610 - 2019-06-11
- FDA Inspection 919150 - 2015-03-24
- FDA Inspection 819591 - 2013-02-21
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