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# Multiple Violations in BD Inspection
- URL: https://www.fdaweb.com/multiple-violations-in-bd-inspection/
- Published: 2025-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:49:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158391

A 5/6-5/22/2024 FDA inspection at the Becton Dickinson/CareFusion 303 facility in San Diego, CA, found multiple violations in the firm’s manufacturing of Pyxis Medication Management System medical devices. An 11/22/2024 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/becton-dickinson-and-companycarefusion-303-inc-691601-11222024?ref=fdaweb.com) details the specific violations as:

- failure to establish and implement procedures for corrective and preventive actions;
- failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failure of design validation to include adequate risk analysis;
- failure to submit a report to FDA no later than 30 days after the firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that the firm markets has malfunctioned and that the device or a similar device that the firm markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur; and
- failure to submit a report of correction or removal initiated to remedy a violation that may present a risk to health within 10 working days of initiating such correction or removal.

FDA says it cannot assess the adequacy of the firm’s responses to the inspection observations. Becton Dickinson was told to take prompt action to correct the violations. The company was told to respond with a list of specific steps it has taken to address the violations and prevent them from recurring, with documentation of the corrections and a schedule for completing the work.