# FDA 483 - Maiden Biosciences - November 28, 2022

Source: https://www.globalkeysolutions.net/records/483/maiden-biosciences/7bde8ccf-3f43-4104-97c9-f9aee76c1bd9

> FDA 483 for Maiden Biosciences on November 28, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Maiden Biosciences
- Inspection Date: 2022-11-28
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: Maiden Biosciences, a medical device manufacturer in Gaithersburg, MD, was cited for significant deficiencies in its quality system during an FDA inspection. The inspection revealed a lack of a designated management representative for quality, absence of a quality policy and plan, and inadequate management review and internal audit procedures. Additionally, the firm failed to establish procedures for identifying training needs and maintaining employee training records.

## Related Officers

- [Jude C. Dike](https://www.globalkeysolutions.net/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.globalkeysolutions.net/companies/maiden-biosciences/8650af85-5536-4a2c-9b5a-471d67f7bcdf

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64