Pure Source, LLC
Form 483 issued March 1, 2018 · Doral, Florida
- Inspection
- Feb 8 – Mar 1, 2018
- Investigators
- Jennifer Lalama· Joanne E. King
- Observations
- 1
- Pages
- 8
- FEI number
- 3002754162
In short: On March 1, 2018, FDA issued a Form 483 with 1 observation to Pure Source, LLC in Doral, Florida (FEI 3002754162) after an inspection that ran Feb 8 – Mar 1, 2018. The investigators were Jennifer Lalama and Joanne E. King. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.63 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Jennifer Lalama
31 documents · 2015–2026
Cites 211.192 (production record review) 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 211.63
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 facilities & equipment. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected Pure Source, LLC?
Jennifer Lalama and Joanne E. King are named on this Form 483, for the inspection of Feb 8 – Mar 1, 2018. Each investigator has a profile showing what they cite most.
When was Pure Source, LLC inspected by FDA?
The inspection ran Feb 8 – Mar 1, 2018, and the Form 483 is dated March 1, 2018.
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.