Tailstorm Health Inc.
Form 483 issued July 21, 2021 · Chandler, Arizona
- Inspection
- Jul 7, 2021
- Investigator
- Michael A. Charles
- Observations
- 4
- Pages
- 6
- FEI number
- 3015929581
In short: On July 21, 2021, FDA issued a Form 483 with 4 observations to Tailstorm Health Inc. in Chandler, Arizona (FEI 3015929581) after an inspection that ran Jul 7, 2021. The investigator was Michael A. Charles. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Equipment for adequate control over micro-organisms is not provided when appropriate for the manufacture, processing, packing…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tailstorm Health Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Tailstorm Health Inc.?
Michael A. Charles is named on this Form 483, for the inspection of Jul 7, 2021. Each investigator has a profile showing what they cite most.
When was Tailstorm Health Inc. inspected by FDA?
The inspection ran Jul 7, 2021, and the Form 483 is dated July 21, 2021.
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.