Fruit of the Earth, Inc.
Form 483 issued December 22, 2021 · Grand Prairie, Texas
- Inspection
- Dec 16 – Dec 22, 2021
- Observations
- 6
- Pages
- 5
- FEI number
- 1420298
In short: On December 22, 2021, FDA issued a Form 483 with 6 observations to Fruit of the Earth, Inc. in Grand Prairie, Texas (FEI 1420298) after an inspection that ran Dec 16 – Dec 22, 2021. Most observations concern dietary supplement CGMP and food CGMP / preventive controls.
At a glance
Observations span 2 systems, led by dietary supplement cgmp.
What FDA observed
Preview: the opening words of each observation- 0121 CFR 114.83
A scheduled process was not established by a qualified person who has expert knowledge acquired through…
- 02
When a process operation deviated from the scheduled process or the equilibrium pH of the finished…
- 0321 CFR 114.100(c)
Departures from a scheduled process having a possible bearing on public health or the safety of…
- 04
You did not establish product specifications for the identity, purity, strength and composition of…
This inspection in context
Questions about this 483
What did FDA find at Fruit of the Earth, Inc.?
FDA listed 6 observations on this Form 483, mostly about dietary supplement CGMP and food CGMP / preventive controls. The opening words of each observation are shown on this page.
When was Fruit of the Earth, Inc. inspected by FDA?
The inspection ran Dec 16 – Dec 22, 2021, and the Form 483 is dated December 22, 2021.
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.