# FDA 483 - ABV Electronics, Inc DBA Sienna Corporation - August 15, 2024

Source: https://www.globalkeysolutions.net/records/483/abv-electronics-inc-dba-sienna-corporation/5cdee8a4-35a4-4fc6-9124-eda6fc4538f4

> FDA 483 for ABV Electronics, Inc DBA Sienna Corporation on August 15, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ABV Electronics, Inc DBA Sienna Corporation
- Inspection Date: 2024-08-15
- Product Type: device
- Office Name: Atlanta District Office
- Summary: ABV Electronics, Inc DBA Sienna Corporation, a contract manufacturer in Suwanee, GA, was cited for multiple quality system deficiencies during an FDA inspection. The observations include inadequate documentation and approval of process validation, lack of written Medical Device Reporting procedures, insufficient complaint handling procedures, and deficiencies in personnel training. These issues indicate a need for significant improvements in the firm's quality management system.

## Related Officers

- [Gamal A. Norton](https://www.globalkeysolutions.net/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.globalkeysolutions.net/companies/abv-electronics-inc-dba-sienna-corporation/525410c0-7b1d-4d9f-a334-56e522f18137

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7