Chromatography Institute Of America FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • Latest inspection OAI · Mar 5, 2025
  • Last warning letter 2025
Inspections 2 1 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Aug 20, 2025
510(k) clearances 0 None on file

Chromatography Institute Of America has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Chromatography Institute Of America, the most recent on Aug 20, 2025.

What these totals cover: FDA records filed under the name "Chromatography Institute Of America" and its spelling variant "Chromatography Institute Of America".

Latest inspection
Mar 5, 2025 · OAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections2Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

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Chromatography Institute Of America FDA Warning Letters

1 warning letter on Aug 20, 2025.

IssuedSubjectIssuing officeClose-out letter
Aug 20, 2025 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

2 inspections from Feb 21, 2012 to Mar 5, 2025.

DateSiteProductClassificationFEI
Mar 5, 2025Castle Rock, COVeterinaryOfficial Action Indicated (OAI)3012069146
Feb 21, 2012Castle Rock, CODrugsVoluntary Action Indicated (VAI)3012069146
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Chromatography Institute Of America: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Aug 20, 2025.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3012069146Castle Rock, CO2Mar 5, 2025

Chromatography Institute Of America and the FDA: common questions

Has Chromatography Institute Of America received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Chromatography Institute Of America. The most recent is dated Aug 20, 2025.

Has Chromatography Institute Of America received an FDA Form 483?

FDA has not published a Form 483 for "Chromatography Institute Of America" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Chromatography Institute Of America?

The most recent FDA inspection on file ended Mar 5, 2025 at Castle Rock, CO and was classified OAI. FDA has 2 inspections of Chromatography Institute Of America on file, 1 of them classified OAI (official action indicated).

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.