Diagnostic Services Of Kansas State, Inc.
Form 483 issued June 20, 2025
- Inspection
- Jun 16 – Jun 20, 2025
- Investigator
- Shafiq S. Ahadi
- Observations
- 4
- Pages
- 4
- FEI number
- 3018083890
In short: On June 20, 2025, FDA issued a Form 483 with 4 observations to Diagnostic Services Of Kansas State, Inc. (FEI 3018083890) after an inspection that ran Jun 16 – Jun 20, 2025. The investigator was Shafiq S. Ahadi. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
3 of 4 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Routine calibration of mechanical and electronic equipment is not performed according to a written program designed…
- 02
Batch production and control records do not include complete information relating to the production and…
- 03
Laboratory records do not include a description of the sample received for testing, the lot number…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Shafiq S. Ahadi
7 documents · 2016–2025
Cites 820.30(b) (design controls) more than any other section. Most of their documents are for sites in Illinois.
The firmDiagnostic Services Of Kansas State, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Diagnostic Services Of Kansas State, Inc.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Diagnostic Services Of Kansas State, Inc.?
Shafiq S. Ahadi is named on this Form 483, for the inspection of Jun 16 – Jun 20, 2025. Each investigator has a profile showing what they cite most.
When was Diagnostic Services Of Kansas State, Inc. inspected by FDA?
The inspection ran Jun 16 – Jun 20, 2025, and the Form 483 is dated June 20, 2025.
How do I get the full Form 483 for Diagnostic Services Of Kansas State, 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.