Fruit of the Earth, Inc.
Form 483 issued April 13, 2017 · Grand Prairie, Texas
- Inspection
- Mar 31 – Apr 13, 2017
- Investigator
- Anh Lac
- Observations
- 4
- Pages
- 4
- FEI number
- 1420298
In short: On April 13, 2017, FDA issued a Form 483 with 4 observations to Fruit of the Earth, Inc. in Grand Prairie, Texas (FEI 1420298) after an inspection that ran Mar 31 – Apr 13, 2017. The investigator was Anh Lac. Most observations concern production and facilities & equipment.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Written production and process control procedures are not documented at…
- 02
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 03
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 04
The quality control unit lacks authority to fully investigate…
This inspection in context
Anh Lac
13 documents · 2012–2017
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmFruit of the Earth, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fruit of the Earth, Inc.?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Fruit of the Earth, Inc.?
Anh Lac is named on this Form 483, for the inspection of Mar 31 – Apr 13, 2017. Each investigator has a profile showing what they cite most.
When was Fruit of the Earth, Inc. inspected by FDA?
The inspection ran Mar 31 – Apr 13, 2017, and the Form 483 is dated April 13, 2017.
How do I get the full Form 483 for Fruit of the Earth, 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.