Becton, Dickinson, and Company/CareFusion 303, Inc.

Warning LetterOpen

Mr. Thomas E. Polen President & CEO Becton, Dickinson, and Company/CareFusion 303, Inc. 1 Becton Drive Franklin Lakes , NJ 07417 United States (b)(6)Issued Nov 22, 2024Center for Devices and Radiological Health

View Letter

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

Violations5

Issue DateNov 22, 2024

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Becton, Dickinson, and Company/CareFusion 303, Inc.
Location: Mr. Thomas E. Polen President & CEO Becton, Dickinson, and Company/CareFusion 303, Inc. 1 Becton Drive Franklin Lakes , NJ 07417 United States (b)(6)
FEI Number: N/A
Country: United States
Issue Date: November 22, 2024
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Becton, Dickinson, and Company/CareFusion 303, Inc. was found to be manufacturing adulterated Pyxis Medication Management System devices (including MedStation ES, ES Anesthesia, and MedBank models) in violation of current good manufacturing practice requirements under 21 CFR Part 820. The FDA inspection in May 2024 identified failures to establish and implement corrective and preventive action procedures, with the company maintaining 544 open software defect tickets, of which 111 were classified as causing catastrophic or severe patient harm. The company submitted responses to the FDA's inspection observations in June, July, and September 2024.

Becton, Dickinson, and Company/CareFusion 303, Inc. FDA Warning Letter, November 22, 2024