The FDA issued a Warning Letter to Dr. Reddy's which states that, during an FDA inspection at the Dr. Reddy's facilities in India, the FDA identified numerous deviations and violations in FDA compliance, and also uncovered a previously unknown and uncontrolled "Custom QC laboratory" (CQC), which engaged in a "practice of substituting repeat tests after failing results." As a result, the FDA, in the Warning Letter, advised Dr Reddy's that: "At Dr. Reddy's Laboratories Limited CTO Units VI and V facilities, we identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs). At Dr. Reddy's Laboratories Limited Unit-VII facility, we found significant violations of CGMP regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211.