UK Devicemaker Warned by FDA on Documentation, Production

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

The May 2 letter cites Amplivox for 10 violations, mostly tied to flawed procedures or documentation.

For example, 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.

In addition, the company’s quality audit procedures did not specify they be conducted by individuals not directly responsible for the matters being audited. Employee training was another concern, as FDA investigators found production employees had not been trained in product testing and product calibration.

Recently, the FDA has issued an increasing number of warning letters citing inadequate employee GMP training.

However, companies consistently claim their employees are trained and that they can prove it by presenting stacks of sign-in sheets from training sessions. This is the training hoax — operators are told in just a few hours about the contents of hundreds of pages of SOPs.

As a result, these reportedly trained professionals can’t possibly have learned the material, and have little recollection of procedures or knowledge of how to handle deviations The results aer defects, recalls and other product problems that cost companies untold billions of dollars.

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