Natural Essentials, Inc.
Form 483 issued March 10, 2023 · Streetsboro, Ohio
- Investigator
- Wen Ning Chan
- Observations
- 3
- Pages
- 4
- FEI number
- 1520307
In short: On March 10, 2023, FDA issued a Form 483 with 3 observations to Natural Essentials, Inc. in Streetsboro, Ohio (FEI 1520307). The investigator was Wen Ning Chan. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Wen Ning Chan
10 documents · 2021–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Ohio.
The firmNatural Essentials, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Natural Essentials, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Natural Essentials, Inc.?
Wen Ning Chan is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Natural Essentials, Inc. inspected by FDA?
This Form 483 is dated March 10, 2023.
How do I get the full Form 483 for Natural Essentials, 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.