# FDA 483 - Azer Scientific, Inc. - December 04, 2023

Source: https://www.keypedia.com/records/483/azer-scientific-inc/4f80a501-3f4e-4f32-929e-76429736476e

> FDA 483 for Azer Scientific, Inc. on December 04, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Azer Scientific, Inc.
- Inspection Date: 2023-12-04
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Azer Scientific, Inc. in Morgantown, PA on December 4, 2023, revealed a significant deficiency in their quality system. The firm failed to adequately maintain complaint files, specifically lacking documented investigations for customer complaints involving foreign material and adverse events related to their glucose products. This indicates a serious lapse in their complaint handling procedures.

## Related Officers

- [Investigator at US Food and Drug Administration](https://www.keypedia.com/people/brian-s-keefer/4fec578b-ca72-4d79-8634-3a9fe7ecd9a5)

Company: https://www.keypedia.com/companies/azer-scientific-inc/91ed54e0-ae76-4d33-8ff2-e3924db3ecea

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8