Want to know what's happening next in healthcare?

MedCityNews is the leading online news source for the business of innovation in healthcare.


“I find MedCity News a great resource for taking the pulse of the market and sourcing potential investment opportunities.”

Bernie Rudnick, Angel investor and advisor, CapGenic Advisors, LLC


Sign up for our daily newsletter


FDA not satisfied with Medtronic’s response to warning letter about manufacturing guideline violations

August 21, 2012 10:50 am by | 0 Comments

recall

(Reuters) - The U.S. health regulator warned Medtronic Inc that certain devices manufactured by the company violated manufacturing and quality regulations that could lead to patient injuries.

The U.S. Food and Drug Administration said in a warning letter dated July 17 that violations included Medtronic's failure to establish adequate procedures for corrective and preventive action and for receiving and evaluating complaints.

The FDA said the medical device maker had responded and described the actions taken to mitigate risks, but the regulator concluded that the response was not adequate.

The regulator asked Medtronic to take prompt action to correct the violations, failing which it could trigger regulatory action without further notice.

Advertisement

Additionally, the FDA also said it will not approve any device that belongs to the device class related to the violations until corrective actions are taken.

Medtronic said on a conference call with analysts that the FDA warnings would not have any financial impact on the company.

Shares of Medtronic, which also posted quarterly results on Tuesday, were down slightly at $41.30 in morning trade on the New York Stock Exchange.

(Reporting by Esha Dey in Bangalore; Editing by Roshni Menon)

Copyright 2014 MedCity News. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
0 comments