# FDA 483 - Precision Biometrics, Inc. - December 21, 2021

Source: https://www.globalkeysolutions.net/records/483/precision-biometrics-inc/7daa1497-cfff-4f24-9870-8c158023cca9

> FDA 483 for Precision Biometrics, Inc. on December 21, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Precision Biometrics, Inc.
- Inspection Date: 2021-12-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Precision Biometrics, Inc. in Seattle, WA, conducted on December 20-21, 2021, identified a significant deficiency in the firm's document control procedures. Specifically, the company failed to adequately establish and implement its control of documents and records procedure, leading to software revisions being released for use before their required Document Change Order (DCO) approval dates. This indicates a breakdown in the firm's quality system regarding document management and software release protocols.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)

Company: https://www.globalkeysolutions.net/companies/precision-biometrics-inc/01623845-7a6d-4092-a41e-0332b6b936c3

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822