# FDA 483 - BC3 TECHNOLOGIES - November 26, 2024

Source: https://www.keypedia.com/records/483/bc3-technologies/713e6d5d-2706-4a1d-a663-89e58b7501fe

> FDA 483 for BC3 TECHNOLOGIES on November 26, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BC3 TECHNOLOGIES
- Inspection Date: 2024-11-26
- Product Type: device
- Office Name: Baltimore District Office
- Summary: BC3 Technologies in Baltimore, MD, a specification developer, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to establish adequate procedures for design control, complaint handling, supplier management, and corrective and preventive actions. Additionally, issues were noted with packaging validation, complaint investigation records, design output documentation, and statistical sampling techniques.

## Related Officers

- [Christina D. Mello](https://www.keypedia.com/people/christina-d-mello/b523622e-d2dd-4ff6-9b2b-74b3134841de)

Company: https://www.keypedia.com/companies/bc3-technologies/01d99b12-40bc-4e3d-9e6e-cc36357a10a9

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa