FDAnews Drug Daily Bulletin

cGMP Violations Draw Warning Letter for Brazilian Company

Oct. 11, 2016

Mappel Industria, a Brazil-based company received a warning letter from the FDA due to significant violations of cGMP regulations for finished pharmaceuticals.

The FDA investigation, which was conducted May 31, found Mappel’s quality control unit failed to approve or reject all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.

In addition, the FDA determined Mappel did not have, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release.

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