Wellington Foods, Inc.
Form 483 issued October 11, 2024 · Corona, California
- Inspection
- Oct 7 – Oct 11, 2024
- Investigator
- Rowena S. Nguyen
- Observations
- 3
- Pages
- 4
- FEI number
- 3008177334
In short: On October 11, 2024, FDA issued a Form 483 with 3 observations to Wellington Foods, Inc. in Corona, California (FEI 3008177334) after an inspection that ran Oct 7 – Oct 11, 2024. The investigator was Rowena S. Nguyen. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Drug products failing to meet established…
- 02
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Rowena S. Nguyen
12 documents · 2022–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in California.
The firmWellington Foods, 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(f)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wellington Foods, Inc.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, production and quality system. The opening words of each observation are shown on this page.
Who inspected Wellington Foods, Inc.?
Rowena S. Nguyen is named on this Form 483, for the inspection of Oct 7 – Oct 11, 2024. Each investigator has a profile showing what they cite most.
When was Wellington Foods, Inc. inspected by FDA?
The inspection ran Oct 7 – Oct 11, 2024, and the Form 483 is dated October 11, 2024.
How do I get the full Form 483 for Wellington Foods, 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.