# FDA 483 - LW Scientific, Inc. - October 19, 2021

Source: https://www.keypedia.com/records/483/lw-scientific-inc/c6dbbeee-79fb-400c-98b7-ce9d4b3b2b7f

> FDA 483 for LW Scientific, Inc. on October 19, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LW Scientific, Inc.
- Inspection Date: 2021-10-19
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of LW Scientific, Inc. in Lawrenceville, GA, revealed significant deficiencies across multiple quality system areas. The firm failed to adequately establish and follow procedures for corrective and preventive actions, complaint handling, personnel training, supplier management, device history records, acceptance activities, and document control. These issues indicate a systemic breakdown in maintaining a compliant quality system for medical device manufacturing.

## Related Officers

- [Dawn M. Braswell](https://www.keypedia.com/people/dawn-m-braswell/6a66fdbb-fff8-4b4b-9f06-320464957b87)
- [investigator](https://www.keypedia.com/people/aigbokhai-a-dirisu/a3dcb5ac-9940-4443-99f2-82537d6e177b)

Company: https://www.keypedia.com/companies/lw-scientific-inc/a44dcf43-f2f1-4b19-b5ba-5e8b06821391

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7