Mylan was hit with an FDA warning letter for serious GMP violations at an API manufacturing facility in Andhra Pradesh, India, including improper handling of raw materials.
The agency investigators found that the procedures for receiving, testing and handling raw materials failed to address the presence of impurities. For example, the company used multiple contract manufacturers for solvents found to be contaminated, but failed to properly document where the solvents were stored.
The company recalled API batches after finding most of them contained levels of contamination over the limits, but its investigation concluded — without scientific support — that recovered solvent containing high contamination levels would not lead to significant API contamination.
The facility also lacked evidence that its cleaning methods prevented contamination or cross-contamination of drugs made on non-dedicated equipment. Two non-dedicated pieces of equipment labeled as “clean” were found to have residual API stains inside.