Hoosier, Inc
Form 483 issued August 21, 2025 · Corona, California
- Inspection
- Aug 18 – Aug 21, 2025
- Investigator
- Linda Galindo
- Observations
- 6
- Pages
- 6
- FEI number
- 3003058119
In short: On August 21, 2025, FDA issued a Form 483 with 6 observations to Hoosier, Inc in Corona, California (FEI 3003058119) after an inspection that ran Aug 18 – Aug 21, 2025. The investigator was Linda Galindo. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance).
At a glance
4 of 6 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 03
Procedures for corrective and preventive action have…
- 04
Complaint files are not…
This inspection in context
Linda Galindo
4 documents · 2024–2026
Cites 820.80 (receiving, in-process, and finished device acceptance) more than any other section. Most of their documents are for sites in California.
The firmHoosier, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hoosier, Inc?
FDA listed 6 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance). The opening words of each observation are shown on this page.
Who inspected Hoosier, Inc?
Linda Galindo is named on this Form 483, for the inspection of Aug 18 – Aug 21, 2025. Each investigator has a profile showing what they cite most.
When was Hoosier, Inc inspected by FDA?
The inspection ran Aug 18 – Aug 21, 2025, and the Form 483 is dated August 21, 2025.
How do I get the full Form 483 for Hoosier, 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.