Tailstorm Health Inc.
Form 483 issued September 24, 2024 · Phoenix, Arizona
- Inspection
- Sep 24, 2024
- Investigator
- Dogbeda F. Mackenzie
- Observations
- 5
- Pages
- 6
- FEI number
- 3022483154
In short: On September 24, 2024, FDA issued a Form 483 with 5 observations to Tailstorm Health Inc. in Phoenix, Arizona (FEI 3022483154) after an inspection that ran Sep 24, 2024. The investigator was Dogbeda F. Mackenzie. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 04
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Dogbeda F. Mackenzie
14 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
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 5 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Tailstorm Health Inc.?
Dogbeda F. Mackenzie is named on this Form 483, for the inspection of Sep 24, 2024. Each investigator has a profile showing what they cite most.
When was Tailstorm Health Inc. inspected by FDA?
The inspection ran Sep 24, 2024, and the Form 483 is dated September 24, 2024.
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.