FDA Inspection 1242963 — Spok, Inc.

Spok, Inc. — FEI 3014158829

The FDA completed an inspection of Spok, Inc. on July 19, 2024 in Alexandria, VA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
July 19, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Alexandria, VA (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
405921 CFR 820.22Quality Audits - defined intervals
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures