# FDA 483 - Biodominium Diagnostics - August 12, 2022

Source: https://www.globalkeysolutions.net/records/483/biodominium-diagnostics/b991c8c1-cb48-4274-8266-15f12046e32a

> FDA 483 for Biodominium Diagnostics on August 12, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biodominium Diagnostics
- Inspection Date: 2022-08-12
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Prime Lab USA Corp. received a Form 483 citing numerous deficiencies in its quality system, primarily related to inadequate validation for its ELISA Test Kits and insufficient environmental controls for product storage and shipping. The firm also failed to adequately establish and implement procedures for complaint handling, corrective and preventive actions, change control, supplier control, device master records, quality audits, acceptance activities, MDR reporting, and management reviews.

## Related Officers

- [Gisselle I. Sensebe](https://www.globalkeysolutions.net/people/gisselle-i-sensebe/fbf83976-9888-44c0-a381-1993a933df4a)
- [investigator](https://www.globalkeysolutions.net/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.globalkeysolutions.net/companies/biodominium-diagnostics/2f16f042-2e3a-479c-a9c0-7294c0737cfc

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6