Spok, Inc
Form 483 issued July 19, 2024 · Alexandria, Virginia
- Inspection
- Jul 15 – Jul 19, 2024
- Investigator
- Tiki Dixon
- Observations
- 4
- Pages
- 4
- FEI number
- 3014158829
In short: On July 19, 2024, FDA issued a Form 483 with 4 observations to Spok, Inc in Alexandria, Virginia (FEI 3014158829) after an inspection that ran Jul 15 – Jul 19, 2024. The investigator was Tiki Dixon. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Process control procedures that describe any process controls necessary to ensure conformance to specifications have…
- 02
Procedmes for corrective and preventive action have…
- 03
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 04
Quality audits were not performed at defined intervals to determine whether the quality system activities and…
This inspection in context
Tiki Dixon
10 documents · 2016–2024
Cites 820.80(a) (receiving, in-process, and finished device acceptance) more than any other section. Most of their documents are for sites in Virginia.
The firmSpok, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.70(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Spok, Inc?
FDA listed 4 observations on this Form 483, mostly about production & process controls, cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Spok, Inc?
Tiki Dixon is named on this Form 483, for the inspection of Jul 15 – Jul 19, 2024. Each investigator has a profile showing what they cite most.
When was Spok, Inc inspected by FDA?
The inspection ran Jul 15 – Jul 19, 2024, and the Form 483 is dated July 19, 2024.
How do I get the full Form 483 for Spok, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.