# FDA 483 - Key Distributed Products dba Advanced Vision Technologies, Inc. - May 10, 2019

Source: https://www.globalkeysolutions.net/records/483/key-distributed-products-dba-advanced-vision-technologies-inc/4c4147d6-152d-43e9-b153-cba079315be6

> FDA 483 for Key Distributed Products dba Advanced Vision Technologies, Inc. on May 10, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Key Distributed Products dba Advanced Vision Technologies, Inc.
- Inspection Date: 2019-05-10
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of Key Distributed Products dba Advanced Vision Technologies, Inc. in Lakewood, CO, a medical device manufacturer, revealed significant deficiencies across its quality system. The firm lacked adequate procedures for controlling nonconforming product, purchasing controls, and corrective and preventive actions. Additionally, the inspection found an incomplete design history file for its soft contact lens products and undocumented equipment calibrations.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.globalkeysolutions.net/companies/key-distributed-products-dba-advanced-vision-technologies-inc/ec9c6511-3f5e-4470-88a8-88e8d18e1a76

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face