# FDA 483 - Moss Tubes Inc. - August 13, 2021

Source: https://www.globalkeysolutions.net/records/483/moss-tubes-inc/946b3ee8-56b0-4d64-82e4-c345e522201f

> FDA 483 for Moss Tubes Inc. on August 13, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Moss Tubes Inc.
- Inspection Date: 2021-08-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Moss Tubes Inc., a medical device manufacturer in Castleton On Hudson, NY, revealed two significant issues related to quality system documentation. The firm failed to adequately maintain device history records, specifically lacking traceability for sterility test reports, and did not properly document design validation results in the design history file.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.globalkeysolutions.net/companies/moss-tubes-inc/a89a34fc-3799-4988-90a3-ff6edf0c4fde

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961