Recipient Name Mr. Thomas E. Polen, Jr., Recipient Title Chairman, CEO and President, CareFusion 213, LLC, 1 Becton Drive Franklin Lakes , NJ 07417-1880 United StatesFEI 3004932373Issued Apr 30, 2026Center for Drug Evaluation and Research (CDER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3004932373.
Violations3
Issue DateApr 30, 2026
Product TypeDrugs
StatusOpen
Letter Details
Firm
CareFusion 213, LLC
Location
Recipient Name Mr. Thomas E. Polen, Jr., Recipient Title Chairman, CEO and President, CareFusion 213, LLC, 1 Becton Drive Franklin Lakes , NJ 07417-1880 United States
FEI Number
3004932373
Country
United States
Issue Date
April 30, 2026
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Subject
CGMP/Finished Pharmaceuticals/Adulterated
CareFusion 213, LLC FDA Warning Letter, April 30, 2026
Talk to a Specialist