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Warning Letters
NexCell Scientific Inc
All Warning Letters
NexCell Scientific Inc
Warning Letter
Open
2 Hughes Ste 200 Irvine , CA 92618-2055 United States
Issued Sep 11, 2026
Center for Biologics Evaluation and Research
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View Letter
Source: FDA, published letter.
FDA published this warning letter; View Letter opens FDA's copy.
Violations
12
Issue Date
Sep 11, 2026
Product Type
Biologics
Status
Open
Overview
Violations
12
Related Form 483s
1
Related Inspections
0
Letter Details
Firm
NexCell Scientific Inc
Location
2 Hughes Ste 200 Irvine , CA 92618-2055 United States
FEI Number
N/A
Country
United States
Issue Date
September 11, 2026
Issuing Office
Center for Biologics Evaluation and Research
Product Type
Biologics
Status
Open
Subject
Unapproved New Drugs/Unlicensed Biological Product Violations
See the 12 Violations
NexCell Scientific Inc FDA Warning Letter, September 11, 2026