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

10:50 am by | 0 Comments


(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.


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)

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