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# QS Violations at BD Manufacturing Facility
- URL: https://www.fdaweb.com/qs-violations-at-bd-manufacturing-facility/
- Published: 2018-10-09T12:00:00.000Z
- Updated: 2026-09-15T00:36:53.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142540

A 5/16-8/1 FDA inspection at the Becton Dickinson manufacturing facility at Franklin, WI, found Quality System Regulation violations in the manufacture of a pre-filled heparin lock flush syringe and pre-filled 0.9% sodium chloride lock flush syringe. A 9/14 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm622651.htm?ref=fdaweb.com) says specific violations were: 

- failing to adequately establish procedures to control environmental conditions;
- failing to adequately establish procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality;
- failing to adequately establish and maintain procedures to identify valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics;
- failing to adequately validate a process whose results cannot be fully verified by subsequent inspection based on established procedure; and
- failing to monitor production processes to ensure that a device conforms to its specifications.

The company was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation of each action, and a timetable for completion.