Purechempros LLC
Form 483 issued November 22, 2022 · Tempe, Arizona
- Inspection
- Nov 17 – Nov 22, 2022
- Investigator
- Nicholas L. Hunt
- Observations
- 7
- Pages
- 5
- FEI number
- 3019411371
In short: On November 22, 2022, FDA issued a Form 483 with 7 observations to Purechempros LLC in Tempe, Arizona (FEI 3019411371) after an inspection that ran Nov 17 – Nov 22, 2022. The investigator was Nicholas L. Hunt. Most observations concern laboratory controls and production.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 03
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 04
The written stability testing…
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 firmPurechempros LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Purechempros LLC?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, production and quality system. The opening words of each observation are shown on this page.
Who inspected Purechempros LLC?
Nicholas L. Hunt is named on this Form 483, for the inspection of Nov 17 – Nov 22, 2022. Each investigator has a profile showing what they cite most.
When was Purechempros LLC inspected by FDA?
The inspection ran Nov 17 – Nov 22, 2022, and the Form 483 is dated November 22, 2022.
How do I get the full Form 483 for Purechempros LLC?
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.