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My DashboardInspection TrackerWarning LettersCalibrate IV Hydration

All Warning Letters

Calibrate IV Hydration

Warning LetterOpen

Recipient Name Neville Campbell, MD, United StatesIssued Oct 13, 2026Center for Biologics Evaluation and Research (CBER)

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations4

Issue DateOct 13, 2026

Product TypeBiologics

StatusOpen

Letter Details

Firm: Calibrate IV Hydration
Location: Recipient Name Neville Campbell, MD, United States
FEI Number: N/A
Country: United States
Issue Date: October 13, 2026
Issuing Office: Center for Biologics Evaluation and Research (CBER)
Product Type: Biologics
Status: Open

Subject

Unapproved New Drugs/Unlicensed Biological Product Violations

Calibrate IV Hydration FDA Warning Letter, October 13, 2026