# FDA 483 - Little Sparrows Technologies, Inc. - October 20, 2021

Source: https://www.keypedia.com/records/483/little-sparrows-technologies-inc/c6871a16-9595-43a7-8493-5645fecfc6a5

> FDA 483 for Little Sparrows Technologies, Inc. on October 20, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Little Sparrows Technologies, Inc.
- Inspection Date: 2021-10-20
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Little Sparrows Technologies, Inc. in Newtonville, MA, a manufacturer of the Bili-Hut Neonatal Phototherapy device, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for design control, maintain a complete design history file, and ensure proper quality audits. Additionally, issues were noted with device history records and personnel training documentation.

## Related Officers

- [Sunita Pandey](https://www.keypedia.com/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)
- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/little-sparrows-technologies-inc/41e81837-13fd-40a9-9e70-322c3ed3c0bb

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