FDA Warns Danish Drugmaker for Testing Failures
The FDA issued a warning letter to DermaPharm for serious GMP violations including inadequate testing of raw materials and finished products.
The agency cited the Danish drugmaker for not testing incoming lots of certain raw materials. The company said it did not test the incoming components because it had already qualified the supplier. But the agency said the firm should not rely on a supplier’s certificate of analysis without confirming the supplier’s test analyses.
The drugmaker also failed to test an over-the-counter drug for identify and strength prior to release.
In response to the inspection findings, the company promised to test finished products for future release. But the agency was not satisfied, in part because the response failed to include testing of reserve samples for batches already distributed in the United States.