UK Devicemaker Warned by FDA on Documentation, Design Changes

Amplivox, a UK subsidiary of Danish company William Demant, got a stern warning from the FDA following a December inspection of its Oxford manufacturing plant.

The May 2 letter cites Amplivox with a total of 10 violations, mostly tied to flawed procedures or documentation. Amplivox makes audiometers, spirometers, vision screeners and other occupational health products.

Amplivox did not have adequate procedures in place to identify, document and validate design changes before they were implemented. Nor did its device design methods include proper design validation, complete with risk analysis. 

Design control problems are a common shortcoming behind FDA warning letters. In 2010, 49 of 89 FDA warning letters included them as a concern, CDRH Office of Compliance Director Steve Silverman said at a recent industry conference.

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