Spanish OTC Drugmaker Nailed for Testing, Records

March 5, 2019

The FDA issued a warning letter to an OTC drug manufacturer in Catalonia, Spain, for inadequate testing of released drug products and incomplete batch records.

During a June 11-14, 2018 inspection of Proandre’s facility, the agency inspector found that the firm released products without testing them for strength and identity.

The company also failed to follow its stability testing schedule, which called for testing at three-month, six-month, one-year and two-year intervals. For one lot of product, the firm performed the three-month test on the same day it was packaged, and the six-month test was conducted nine months after the initial stability testing.

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