Pure Source, LLC
Form 483 issued August 14, 2019 · Doral, Florida
- Inspection
- Jul 23 – Aug 14, 2019
- Investigator
- Joanne E. King
- Observations
- 3
- Pages
- 4
- FEI number
- 3002754162
In short: On August 14, 2019, FDA issued a Form 483 with 3 observations to Pure Source, LLC in Doral, Florida (FEI 3002754162) after an inspection that ran Jul 23 – Aug 14, 2019. The investigator was Joanne E. King. Most observations concern quality system and production.
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Deviations from written production and process control procedures are…
- 03
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
This inspection in context
Joanne E. King
34 documents · 2013–2026
Cites 211.42 (design and construction features) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pure Source, LLC?
FDA listed 3 observations on this Form 483, mostly about quality system, production and materials. The opening words of each observation are shown on this page.
Who inspected Pure Source, LLC?
Joanne E. King is named on this Form 483, for the inspection of Jul 23 – Aug 14, 2019. Each investigator has a profile showing what they cite most.
When was Pure Source, LLC inspected by FDA?
The inspection ran Jul 23 – Aug 14, 2019, and the Form 483 is dated August 14, 2019.
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.