Vintage Chemical Inc.
Form 483 issued April 12, 2023 · Fort Wayne, Indiana
- Inspection
- Apr 10 – Apr 12, 2023
- Investigator
- Cori S. Rundi
- Observations
- 3
- Pages
- 3
- FEI number
- 3002718545
In short: On April 12, 2023, FDA issued a Form 483 with 3 observations to Vintage Chemical Inc. in Fort Wayne, Indiana (FEI 3002718545) after an inspection that ran Apr 10 – Apr 12, 2023. The investigator was Cori S. Rundi. Most observations concern facilities & equipment and materials.
At a glance
Facilities & equipment and materials account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 02
Your firm failed to conduct at least one test to verify the identity of incoming raw…
- 03
Written procedures are not established to assure that correct labels, labeling, and packaging materials are…
This inspection in context
Cori S. Rundi
1 document · 2023
Cites 211.130 (packaging and labeling operations) more than any other section. Most of their documents are for sites in Indiana.
The firmVintage Chemical 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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vintage Chemical Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, materials and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Vintage Chemical Inc.?
Cori S. Rundi is named on this Form 483, for the inspection of Apr 10 – Apr 12, 2023. Each investigator has a profile showing what they cite most.
When was Vintage Chemical Inc. inspected by FDA?
The inspection ran Apr 10 – Apr 12, 2023, and the Form 483 is dated April 12, 2023.
How do I get the full Form 483 for Vintage Chemical 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.