FDA Update

BD receives FDA warning letter over quality system violations

Becton Dickinson (BD) has received a warning letter from the FDA regarding quality system violations at a facility that manufactures its Pyxis medication management system. The FDA identified several concerns, including:

• Failure to adequately investigate complaints: The FDA found over 92,000 complaints related to Pyxis system malfunctions causing medication delivery delays, including reports of life-threatening situations.
• Medication errors: There were 70 complaints of incorrect medications being dispensed and eight complaints of potential electrical safety issues.
• Insufficient corrective actions: The FDA determined that BD’s investigations and corrective actions were inadequate to address the reported problems.

This warning letter highlights the critical importance of robust quality systems in medical device manufacturing. BD is expected to take prompt action to address the FDA’s concerns and ensure the safety and effectiveness of its Pyxis systems.

For the original warning letter, please visit the FDA’s website.

We are dedicated to navigating this industry diligently, underscoring our unwavering commitment to you, our valued clients. As always, your trust in mdi Consultants drives us to continually improve and deliver excellence in every aspect of our operations. mdi can provide you guidance to assure you would be able to deal with any future FDA inspection.

For any further questions regarding your quality system as well as how to handle the process of receiving and FDA 483 and Warning Letter, please email mdi Consultants at [email protected] RE: FDA483/Warning.