# FDA 483 - Fisher Wallace Laboratories Inc. - March 15, 2023

Source: https://www.keypedia.com/records/483/fisher-wallace-laboratories-inc/21f680f4-48fc-4a0a-b7de-13aa63f78aaa

> FDA 483 for Fisher Wallace Laboratories Inc. on March 15, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fisher Wallace Laboratories Inc.
- Inspection Date: 2023-03-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Fisher Wallace Laboratories Inc. in Brooklyn, NY, was inspected and received 11 observations related to significant deficiencies in their quality system for manufacturing Fisher Wallace Stimulators. The observations highlight issues across design control, complaint handling, MDR reporting, supplier management, and record keeping, indicating a broad lack of adherence to medical device regulations. The firm failed to adequately establish and follow procedures for design plans, MDR reporting, complaint investigations, incoming product acceptance, control over contractors, CAPA, design changes, and record keeping.

## Related Documents

- [483 - 2025-05-13](https://www.keypedia.com/records/483/fisher-wallace-laboratories-inc/737b6639-7390-4ddb-8671-cbef1b917afa)

## 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/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961