FDA Inspection
Spok, Inc.Spok, Inc. – FDA Inspection, Jul 19, 2024
Record Details
This FDA Inspection record concerns Spok, Inc., with an inspection on July 19, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ae27b357-24a8-4209-abf7-19e61f0f3526
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1242963
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Spok, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 29, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 5, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Spok, Inc.
- FDA Inspection 1168317 - 2022-04-29
- FDA Inspection 1089418 - 2019-04-05
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