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

Source: https://www.keypedia.com/records/483/human-biosciences-inc/14510d4a-fcfd-4509-adc4-83a8fc06d51d

> FDA 483 for Human Biosciences, Inc. on February 15, 2022. Product: devices. 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: devices
- Office Name: Baltimore District Office
- Summary: During an FDA inspection conducted from February 10-15, 2022, Human Biosciences, Inc., a medical device manufacturer located in Gaithersburg, MD, received a Form FDA 483 citing three significant observations related to its quality system. These observations indicate potential non-compliance with regulatory requirements for medical device manufacturing.The first observation noted that design output for their SkinTemp® II device was not adequately documented before release. Specifically, the 7"x7" sheet size of the device lacked defined specifications, packaging specifications, and inclusion in the device master record, failing to conform to design input requirements.Secondly, the firm's procedures for design review were found to be inadequately established. Although a retrospective Design History File for SkinTemp® II was created in 2019 to comply with regulations, planned and conducted design reviews at appropriate stages of the process were omitted.Finally, procedures for the rework of nonconforming product were deemed insufficient. The company lacked adequate procedures for reworked materials, particularly concerning retesting and reevaluation to ensure they met approved specifications.Human Biosciences, Inc. has committed to correcting all identified deficiencies within 12 weeks, as noted in the inspection report. This response is critical for ensuring product quality and regulatory compliance.

## Related Documents

- [WARNING_LETTER - 2011-10-18](https://www.keypedia.com/records/warning_letter/human-biosciences-inc/7c034e6a-4a3a-4e4e-aaad-635796a40818)
- [483 - 2022-02-15](https://www.keypedia.com/records/483/human-biosciences-inc/36857491-ce86-4d91-8208-3c8fe12a2906)

## Related Officers

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

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

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