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The US Food and Drug Administration (FDA) on Tuesday released two new warning letters for active pharmaceutical ingredient manufacturers Badrivishal Chemicals & Pharmaceuticals and Lumis Global Pharmaceuticals, both sent 2 March.
The letter for Talegaon Dabhade, India-based Badrivishal follows a three-day inspection from last August in which FDA uncovered that the site’s water purification system was not adequately monitored and controlled.
FDA investigators also found “a large number of trash bags behind a building” containing “torn original laboratory and production records, such as analytical test reports,” as well as water testing reports and sample notebooks, though two days later, investigators found that the bags had disappeared.
In addition, the company was found to have impurity testing chromatograms containing “unexplained discrepancies in run times as well as aborted runs and reprocessing of data for at least six batches over at least three months.”
For Wuhan, China-based Lumis, FDA found that for multiple APIs, the company generated certificates of analysis (COA) “by copying and pasting analytical results from the original API manufacturers, replacing the manufacturers’ information with your letterhead, then issuing these COA to your customers. You omitted critical information, including the original manufacturers’ names and addresses and the names, addresses, and telephone numbers of laboratories that performed the testing.”
FDA explains further why this information is so critical: “Customers and regulators rely on COA for information about the quality and sourcing of drugs and their components. Omitting information from COA compromises supply-chain accountability and traceability, and may put consumers at risk.”
Badrivishal Chemicals & Pharmaceuticals 3/2/17
Lumis Global Pharmaceuticals Co. Ltd. 3/2/17
Tags: warning letters, API manufacturers, water and pharmaceuticals