Fruit of the Earth, Inc.
Form 483 issued March 31, 2023 · Grand Prairie, Texas
- Investigator
- Michelle A. Krayer
- Observations
- 1
- Pages
- 2
- FEI number
- 1420298
In short: On March 31, 2023, FDA issued a Form 483 with 1 observation to Fruit of the Earth, Inc. in Grand Prairie, Texas (FEI 1420298). The investigator was Michelle A. Krayer. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.58 (maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.58 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Buildings used in the manufacturing, processing and packing of a drug product are not maintained in…
This inspection in context
Michelle A. Krayer
11 documents · 2019–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Texas.
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 211.58
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 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.58 (maintenance). The opening words of each observation are shown on this page.
Who inspected Fruit of the Earth, Inc.?
Michelle A. Krayer is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Fruit of the Earth, Inc. inspected by FDA?
This Form 483 is dated March 31, 2023.
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.