FDA inspectors found Alchymars failed to adequately maintain equipment used to make active pharmaceutical ingredients for the U.S. market. Over-the-counter drugmakers GC America and Sato Pharmaceutical also received warning letters.
The FDA has warned an Indian drug ingredient manufacturer over the “various levels of disrepair” found at its facility, marking the second time in eight years that the agency has scolded the company.
FDA inspectors performed an unannounced inspection of Alchymars ICM SM Private Limited’s facility in Tamil Nadu, India, late last year. Inspectors found deviations from manufacturing standards at the active pharmaceutical ingredient (API) plant and, after Alchymars’ response failed to allay their concerns, sent a warning letter.
The letter describes failures to adequately maintain equipment used to manufacture APIs for the U.S. market. Cracked, taped and deteriorating gaskets, rust-like residues on product-contact surfaces and wet paint during production activities were among the problems documented by the inspectors.
Alchymars classed the conditions as “OK” in its cleaning and preventive maintenance records. Responding to the FDA, the company said the inaccurate recordkeeping stemmed from “insufficient inspection rigor” and blamed the equipment’s state on inadequacies in the cleaning program and the absence of a lifecycle management program.
In response, Alchymars began repairing equipment and overhauling procedures for cleaning, maintenance, inspection and gasket management. However, the FDA found the company’s response was inadequate because it lacked testing for residues found in the equipment and failed to explain how the existing quality system overlooked the obvious equipment maintenance issues.
The FDA communicated its conclusions eight years after sending a prior warning letter to Alchymars. The earlier warning described failures to properly maintain equipment, including a manhole gasket that was “deteriorating and wrapped in peeling tape.” Inspectors found an equipment washroom in “a filthy condition with damaged tiles and standing water.”
Alchymars satisfied the FDA that the deviations had been addressed, leading the agency to send a closeout letter in 2023. The FDA shared details of the new warning letter days after including Alchymars on a list of companies that are late in paying an annual facility fee under the Generic Drug User Fee Amendments. Companies cannot cite facilities with unpaid fees in certain filings to the FDA.
The Alchymars warning letter was one of several manufacturing-related notices in the FDA’s latest batch of compliance notices. Over-the-counter drugmakers GC America and Sato Pharmaceutical also received warning letters.
FDA inspectors found that GC staff at a plant in Illinois failed to test components before using them to make drug products. The failures included the absence of identity testing for each lot of components at high risk of contamination. Sato received a warning letter after inspectors found a “fundamentally unsuitable” space being used for aseptic filling.
