Nature's Innovation, Inc.
Form 483 issued May 14, 2019 · Buford, Georgia
- Inspection
- Apr 23 – May 14, 2019
- Investigator
- Veronica Fuentes
- Observations
- 9
- Pages
- 5
- FEI number
- 3007963810
In short: On May 14, 2019, FDA issued a Form 483 with 9 observations to Nature's Innovation, Inc. in Buford, Georgia (FEI 3007963810) after an inspection that ran Apr 23 – May 14, 2019. The investigator was Veronica Fuentes. Most observations concern quality system and production.
At a glance
Quality system and production account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
Procedures describing the handling of all written and oral complaints regarding a drug…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Veronica Fuentes
22 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Georgia.
The firmNature's Innovation, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nature's Innovation, Inc.?
FDA listed 9 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Nature's Innovation, Inc.?
Veronica Fuentes is named on this Form 483, for the inspection of Apr 23 – May 14, 2019. Each investigator has a profile showing what they cite most.
When was Nature's Innovation, Inc. inspected by FDA?
The inspection ran Apr 23 – May 14, 2019, and the Form 483 is dated May 14, 2019.
How do I get the full Form 483 for Nature's Innovation, 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.