Vintage Chemical Inc.
Form 483 issued November 20, 2023 · Fort Wayne, Indiana
- Inspection
- Jan 13 – Nov 20, 2023
- Investigator
- Boiss S. Fundtorbuyreso
- Observations
- 3
- Pages
- 4
- FEI number
- 3002718545
In short: On November 20, 2023, FDA issued a Form 483 with 3 observations to Vintage Chemical Inc. in Fort Wayne, Indiana (FEI 3002718545) after an inspection that ran Jan 13 – Nov 20, 2023. The investigator was Boiss S. Fundtorbuyreso. 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 specific test to verify the identity of incoming…
- 03
Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory…
This inspection in context
Boiss S. Fundtorbuyreso
1 document · 2023
Cites 211.165 (testing and release for distribution) 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 laboratory controls. The opening words of each observation are shown on this page.
Who inspected Vintage Chemical Inc.?
Boiss S. Fundtorbuyreso is named on this Form 483, for the inspection of Jan 13 – Nov 20, 2023. Each investigator has a profile showing what they cite most.
When was Vintage Chemical Inc. inspected by FDA?
The inspection ran Jan 13 – Nov 20, 2023, and the Form 483 is dated November 20, 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.