# FDA 483 - Fisher Wallace Laboratories Inc. - May 13, 2025

Source: https://www.keypedia.com/records/483/fisher-wallace-laboratories-inc/737b6639-7390-4ddb-8671-cbef1b917afa

> FDA 483 for Fisher Wallace Laboratories Inc. on May 13, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fisher Wallace Laboratories Inc.
- Inspection Date: 2025-05-13
- Product Type: device
- Office Name: New York District Office
- Summary: Fisher Wallace Laboratories Inc. in Brooklyn, NY, a manufacturer of Cranial Electrotherapy Stimulators, received a Form FDA 483 with six observations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate control of non-conforming product, ineffective corrective and preventive actions, poor complaint handling, incomplete design verification, and insufficient supplier controls. Additionally, the firm failed to submit a required Medical Device Report for a serious injury in a timely manner.

## Related Documents

- [483 - 2023-03-15](https://www.keypedia.com/records/483/fisher-wallace-laboratories-inc/21f680f4-48fc-4a0a-b7de-13aa63f78aaa)

## Related Officers

- [Jacqueline S. Warner](https://www.keypedia.com/people/jacqueline-s-warner/d001f4ec-db46-4d78-a5dd-efea7ddfb893)

Company: https://www.keypedia.com/companies/fisher-wallace-laboratories-inc/24abbbef-09e9-4340-a506-834ecb394e59

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d