cGMP Violations Result in Warning Letter for Brazilian Company
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.
Mappel also failed to follow written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Finally, the FDA said, the company failed to maintain production, control, or distribution records associated with a batch of a drug product for at least one year after the expiration date of the batch.
In its response Mappel stated that it did not fully comprehend that such products were regulated by the FDA as over-the-counter drugs and that it has no intentions of manufacturing OTC drug products, although it doesn’t state in the letter what kind of pharmaceutical goods are being produced.
Why are cGMPs So Important? This is ideal for pre-employment training or as a GMP refresher course. It’s an essential tool for drug company training professionals, HR departments, manufacturing directors and supervisors, QA/QC personnel, anybody new to the industry and consultants/service providers. Act now and find out what’s all the buzz!