Therapak Corporation
Form 483 issued February 12, 2026 · Claremont, California
- Inspection
- Feb 10 – Feb 12, 2026
- Investigator
- Linda Galindo
- Observations
- 2
- Pages
- 4
- FEI number
- 3010882984
In short: On February 12, 2026, FDA issued a Form 483 with 2 observations to Therapak Corporation in Claremont, California (FEI 3010882984) after an inspection that ran Feb 10 – Feb 12, 2026. The investigator was Linda Galindo.
What FDA observed
Preview: the opening words of each observation- 01
Analysis of data indicating the quality management system is not suitable, adequate, or effective was not…
- 02
Procedures for the feedback process…
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 firmTherapak Corporation history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Therapak Corporation?
FDA listed 2 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Therapak Corporation?
Linda Galindo is named on this Form 483, for the inspection of Feb 10 – Feb 12, 2026. Each investigator has a profile showing what they cite most.
When was Therapak Corporation inspected by FDA?
The inspection ran Feb 10 – Feb 12, 2026, and the Form 483 is dated February 12, 2026.
How do I get the full Form 483 for Therapak Corporation?
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.