Pure Source, LLC
Form 483 issued August 31, 2023 · Doral, Florida
- Inspection
- Aug 23 – Aug 31, 2023
- Investigator
- Ronald Ifraimov
- Observations
- 1
- Pages
- 3
- FEI number
- 3002754162
In short: On August 31, 2023, FDA issued a Form 483 with 1 observation to Pure Source, LLC in Doral, Florida (FEI 3002754162) after an inspection that ran Aug 23 – Aug 31, 2023. The investigator was Ronald Ifraimov. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.50 (purchasing controls).
At a glance
1 of 1 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
The evaluation of potential suppliers, contractors and…
This inspection in context
Ronald Ifraimov
10 documents · 2014–2026
Cites 820.30(b) (design controls) more than any other section. Most of their documents are for sites in Florida.
The firmPure Source, LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.50(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pure Source, LLC?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.50 (purchasing controls). The opening words of each observation are shown on this page.
Who inspected Pure Source, LLC?
Ronald Ifraimov is named on this Form 483, for the inspection of Aug 23 – Aug 31, 2023. Each investigator has a profile showing what they cite most.
When was Pure Source, LLC inspected by FDA?
The inspection ran Aug 23 – Aug 31, 2023, and the Form 483 is dated August 31, 2023.
How do I get the full Form 483 for Pure Source, 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.