Creative Testing Solutions
Form 483 issued August 29, 2025 · Tempe, Arizona
- Inspection
- Aug 18 – Aug 29, 2025
- Investigators
- Emily S. McGann· William F. Lagud
- Observations
- 2
- Pages
- 4
- FEI number
- 3000204058
In short: On August 29, 2025, FDA issued a Form 483 with 2 observations to Creative Testing Solutions in Tempe, Arizona (FEI 3000204058) after an inspection that ran Aug 18 – Aug 29, 2025. The investigators were Emily S. McGann and William F. Lagud. Most observations concern hCT/P and biologics CGMP; the most-cited regulation is 21 CFR 1271.80 (what are the general requirements for donor testing?).
At a glance
HCT/P and biologics cgmp account for 2 of 2 observations.
Most cited: 21 CFR 1271.80(c) (1×) · 606.100(c) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Testing for communicable disease agents was not performed in accordance…
- 02
Failure to perform a thorough investigation and make a record of the conclusions and follow-up…
This inspection in context
Emily S. McGann
6 documents · 2024–2026
Cites 1271.50 (how do i determine whether a donor is eligible?) more than any other section. Most of their documents are for sites in Arizona.
The firmCreative Testing Solutions history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.80(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Creative Testing Solutions?
FDA listed 2 observations on this Form 483, mostly about hCT/P and biologics CGMP. The most-cited regulation is 21 CFR 1271.80 (what are the general requirements for donor testing?). The opening words of each observation are shown on this page.
Who inspected Creative Testing Solutions?
Emily S. McGann and William F. Lagud are named on this Form 483, for the inspection of Aug 18 – Aug 29, 2025. Each investigator has a profile showing what they cite most.
When was Creative Testing Solutions inspected by FDA?
The inspection ran Aug 18 – Aug 29, 2025, and the Form 483 is dated August 29, 2025.
How do I get the full Form 483 for Creative Testing Solutions?
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.