Louisville APL Diagnostics Inc.

Failure to validate the heat sealing equipment; failure to validate the software in use to calculate GPL and MPL unit values; failure to provide adequate documentation to assure that the product will maintain its functionality throughout its labeled expiration date; and the quality assurance program failed to respond to device quality problems identified as a result of consumer complaints and retained product testing.

You have failed to validate the software in use _____ to calculate GPL and MPL unit values. These test values are used in the release of finished product. This specific application has never been validated for this intended use by your firm or the software supplier. You could provide no documentation that the results produced are comparable to the data obtained previously by manual calculations. There is no assurance that absorbance values are properly converted to MPL and GPL units to meet final product specifications.

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