# FDA 483 - Human Biosciences, Inc. - February 15, 2022

Source: https://www.keypedia.com/records/483/human-biosciences-inc/36857491-ce86-4d91-8208-3c8fe12a2906

> FDA 483 for Human Biosciences, Inc. on February 15, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Human Biosciences, Inc.
- Inspection Date: 2022-02-15
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: Human Biosciences, Inc. in Gaithersburg, MD, a medical device manufacturer, was cited for three observations during an FDA inspection. The inspection revealed deficiencies in design control, specifically regarding inadequate documentation of design output for their SkinTemp® II device and a lack of established procedures for design reviews. Additionally, the firm failed to establish adequate rework procedures for nonconforming products.

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- [483 - 2022-02-15](https://www.keypedia.com/records/483/human-biosciences-inc/14510d4a-fcfd-4509-adc4-83a8fc06d51d)

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Company: https://www.keypedia.com/companies/human-biosciences-inc/1396dcaa-6c36-4bff-910b-20937317db70

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