# FDA 483 - Calyxo, Inc. - March 04, 2022

Source: https://www.keypedia.com/records/483/calyxo-inc/3867de13-04d9-4127-8eda-378a29adf430

> FDA 483 for Calyxo, Inc. on March 04, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Calyxo, Inc.
- Inspection Date: 2022-03-04
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Calyxo, Inc. in Pleasanton, CA was inspected from February 28 to March 4, 2022, and received a Form FDA 483 with two observations. The inspection revealed inadequate procedures for the control and distribution of finished devices, including issues with shelf life updates and bioburden monitoring. Additionally, the firm failed to adequately establish and implement procedures for monitoring and controlling validated process parameters.

## Related Officers

- [investigator](https://www.keypedia.com/people/elizabeth-a-dakan/f701338d-0484-431b-8bd5-9db442b5f079)

Company: https://www.keypedia.com/companies/calyxo-inc/09aa30cc-477f-41b2-a164-a470ffcbd437

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b