Company
United StatesMycoScience Labs, LLC, Willington, CT – FDA Inspections
Inspection records and compliance data for MycoScience Labs, LLC in Willington, Connecticut. 7 FDA inspections on record, 1 Form 483, last inspected January 16, 2025.
Company Profile
This profile covers MycoScience Labs, LLC based in Willington, Connecticut, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 2
- NAI
- 5
- Form 483s
- 1
- Warning letters
- 0
First inspected March 26, 2009. Last inspected January 16, 2025.
Most cited issue areas
- Contamination control, Lack of or inadequate procedures1 inspection
- DHR content1 inspection
- Documentation of validated process performance1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 16, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1234863 |
| February 15, 2024 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1230344 |
| June 11, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1094610 |
| August 25, 2017 | NAI | Biologics, Medical Devices & Rad Health · Blood and Blood Products | 1022864 |
| March 24, 2015 | VAI | Biologics, Medical Devices & Rad Health · Compliance: Devices | 919150 |
| February 21, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 819591 |
| March 26, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 572947 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
MycoScience Labs, LLC
FEI Number
1000120776
Address
25 Village Hill Rd, Willington, Connecticut 06279, United States
Country
United States
ID: efea64d2-e9d9-40c0-b439-a9cb6710694f