# FDA 483 - Davryan Laboratories, Inc. - October 11, 2023

Source: https://www.keypedia.com/records/483/davryan-laboratories-inc/4e73e832-f757-4311-986a-08ec33da5b6a

> FDA 483 for Davryan Laboratories, Inc. on October 11, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Davryan Laboratories, Inc.
- Inspection Date: 2023-10-11
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Davryan Laboratories, Inc. in Porter, IN, conducted from October 10-11, 2023, identified a significant deficiency in the firm's quality system. The company failed to establish adequate procedures for controlling nonconforming Class II finished products. This indicates a lack of proper controls for identifying, documenting, evaluating, segregating, and disposing of products that do not meet specified requirements.

## Related Documents

- [483 - 2019-12-17](https://www.keypedia.com/records/483/davryan-laboratories-inc/4761a91e-875f-424c-a437-a0c40a01457c)

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.keypedia.com/companies/davryan-laboratories-inc/0dfc120f-19f4-418f-b184-f2fd358c6847

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0