FDA Hits Tennessee Drugmaker for Falling Short on Testing

June 14, 2019

Multiple violations at Lexia’s Franklin, Tennessee facility netted the drugmaker a Form 483 from the FDA following a March 6-7 inspection.

The agency investigator found problems with lot testing and the use of an expired active ingredient, among other issues.

In one instance, a lot manufactured in December 2017 used an active ingredient that had expired in December 2015. One lot only underwent only partial quality testing—and the facility conducted no quality tests for four lots, the investigator found.

The laboratory manager admitted that the facility accepted product used in manufacturing without a certificate of analysis from the supplier. It also didn’t conduct identity or strength testing on an active ingredient.

The laboratory also failed to confirm that all finished drug products conformed to specifications for identity and strength of active ingredients.

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