# FDA 483 - Spok, Inc. - July 19, 2024

Source: https://www.keypedia.com/records/483/spok-inc/c34bfb41-9f43-428c-b4ef-32a12a98a4ca

> FDA 483 for Spok, Inc. on July 19, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spok, Inc.
- Inspection Date: 2024-07-19
- Product Type: other
- Office Name: Office of Regulatory Affairs
- Summary: During an inspection, Spok, Inc., a manufacturer in Alexandria, VA, was cited for significant deficiencies in its quality system. The firm failed to adequately establish, document, and implement critical procedures related to design controls, corrective and preventive actions, purchasing, and internal quality audits. These issues indicate a systemic breakdown in maintaining a compliant quality management system.

## Related Officers

- [Tiki Dixon](https://www.keypedia.com/people/tiki-dixon/b3160a2c-ef16-4fa2-b9b9-4c3a0ed17c5b)

Company: https://www.keypedia.com/companies/spok-inc/2e1335ee-3dcb-4ae5-ae78-f8047bb75760

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64