Puremedy Inc
Form 483 issued July 26, 2024 · Westlake Village, California
- Inspection
- Jul 15 – Jul 26, 2024
- Investigator
- Darren S. Brown
- Observations
- 9
- Pages
- 6
- FEI number
- 3011137754
In short: On July 26, 2024, FDA issued a Form 483 with 9 observations to Puremedy Inc in Westlake Village, California (FEI 3011137754) after an inspection that ran Jul 15 – Jul 26, 2024. The investigator was Darren S. Brown. Most observations concern laboratory controls and facilities & equipment.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
There is no written assessment of stability of homeopathic ding products based at least on testing…
This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmPuremedy Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Puremedy Inc?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Puremedy Inc?
Darren S. Brown is named on this Form 483, for the inspection of Jul 15 – Jul 26, 2024. Each investigator has a profile showing what they cite most.
When was Puremedy Inc inspected by FDA?
The inspection ran Jul 15 – Jul 26, 2024, and the Form 483 is dated July 26, 2024.
How do I get the full Form 483 for Puremedy 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.