# FDA 483 - BK Medical Holding Company - May 27, 2022

Source: https://www.keypedia.com/records/483/bk-medical-holding-company/01c02a91-48e2-443c-a2fb-963f8851d948

> FDA 483 for BK Medical Holding Company on May 27, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BK Medical Holding Company
- Inspection Date: 2022-05-27
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: BK Medical Holding Company, an initial importer in Burlington, MA, was cited for significant deficiencies in its quality system during an FDA inspection. The firm lacked adequately established procedures for receiving, reviewing, and evaluating complaints, as well as for implementing corrective and preventive actions. Additionally, procedures for training and identifying training needs were not established, leading to employees processing complaints before receiving proper training.

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/bk-medical-holding-company/5ace7e86-c6cf-4763-8ba1-8b4ad413ec8b

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94