Missing, Flawed MDR Procedures Land Warning for UK Company

A British cardiac device company earned an FDA warning letter over its failure to establish medical device reporting (MDR) procedures. The letter to APC Medical, dated Dec. 23, was posted to the FDA website last month. The warning followed a Sept. 19 to 22 inspection of the company’s Welwyn Garden City, Hartfordshire, facility. APC had already tried to respond and establish proper MDR guidelines when the FDA issued the warning letter, but its attempts were deemed inadequate.
The GMP Letter