# FDA 483 - MycoScience Labs, LLC - February 15, 2024

Source: https://www.keypedia.com/records/483/mycoscience-labs-llc/36dd11a2-7346-4a47-a4ec-5a46c0a3e89c

> FDA 483 for MycoScience Labs, LLC on February 15, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MycoScience Labs, LLC
- Inspection Date: 2024-02-15
- Product Type: device
- Office Name: New England District Office
- Summary: MycoScience Labs, LLC, a medical device contract manufacturer in Willington, CT, was cited for seven observations during an FDA inspection. The inspection revealed significant deficiencies in process validation, control of non-conforming products, corrective and preventive actions, environmental controls, process controls, supplier management, and device history records. These issues indicate a lack of robust quality system procedures impacting the manufacturing of medical devices.

## Related Officers

- [Power Trader/Data Scientist](https://www.keypedia.com/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

Company: https://www.keypedia.com/companies/mycoscience-labs-llc/efea64d2-e9d9-40c0-b439-a9cb6710694f

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144