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Home » Tennessee Specs Developer Cited for Lacking Procedures

Tennessee Specs Developer Cited for Lacking Procedures

July 30, 2019

The FDA has slammed specifications developer Blephex for a lack of established procedures at its Franklin, Tennessee facility.

Following its March 27-28 investigation of the site, the agency scolded the company for not having procedures in place to receive, document, review and evaluate complaints.

Additionally, the investigator noted that the firm had no medical device reporting (MDR) procedures established.

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