Tailstorm Health Inc.
Form 483 issued May 23, 2025 · Chandler, Arizona
- Inspection
- May 14 – May 23, 2025
- Investigators
- Nicholas L. Hunt· Ronda R. Loyd Jones
- Observations
- 5
- Pages
- 6
- FEI number
- 3015929581
In short: On May 23, 2025, FDA issued a Form 483 with 5 observations to Tailstorm Health Inc. in Chandler, Arizona (FEI 3015929581) after an inspection that ran May 14 – May 23, 2025. The investigators were Nicholas L. Hunt and Ronda R. Loyd Jones. Most observations concern facilities & equipment and quality system.
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The separate or defined areas and control systems necessary to prevent contamination…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
- 04
Routine inspection and checking of equipment is not performed according to a written program designed…
This inspection in context
Nicholas L. Hunt
38 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
The firmTailstorm Health Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tailstorm Health Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Tailstorm Health Inc.?
Nicholas L. Hunt and Ronda R. Loyd Jones are named on this Form 483, for the inspection of May 14 – May 23, 2025. Each investigator has a profile showing what they cite most.
When was Tailstorm Health Inc. inspected by FDA?
The inspection ran May 14 – May 23, 2025, and the Form 483 is dated May 23, 2025.
How do I get the full Form 483 for Tailstorm Health 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.