# FDA 483 - E.M. Adams Co., Inc. - November 14, 2022

Source: https://www.keypedia.com/records/483/em-adams-co-inc/e717dd98-edd3-4a2b-8f45-6ddab0157623

> FDA 483 for E.M. Adams Co., Inc. on November 14, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: E.M. Adams Co., Inc.
- Inspection Date: 2022-11-14
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: E.M. Adams Co., Inc. in Fort Pierce, FL, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish fundamental procedures for corrective and preventive actions, complaint handling, control of non-conforming product, and document control. These issues indicate a lack of basic controls necessary for compliant manufacturing operations.

## Related Officers

- [Alex J. Wild](https://www.keypedia.com/people/alex-j-wild/bb1b66b3-19b9-480e-af0b-f06f8de0d930)

Company: https://www.keypedia.com/companies/em-adams-co-inc/4a799033-9221-4c46-8f0f-189a3ebcf342

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6