The U.K. is soon pulling out of the European Union, separating its drug oversight from that of the European Medicines Agency, but for now they are acting in unison, like with an action against a Taiwanese sterile API maker.
The EMA, on the recommendation of U.K. inspectors, has pulled the license of Savior Lifetec Corp. in Chunan Chen, Miaoli County, in Taiwan after an inspection in March turned up a variety of problems. It also recommended that the sterile drugmaker recall all batches of APIs from EU markets that are not considered essential. It has told the company not to ship more product until it can return to compliance.
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The recommendations against Savior came after inspectors said they found a lack of technical knowledge of basic aseptic sterile processing, including autoclave and dry heat sterilization of equipment, adequate VHP load pattern design and application, and media fills and environmental monitoring.
The EMA said that where there are APIs that are critically essential to a market, authorities should “enact measures to ensure continued supplies where appropriate.”
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Savior is not the first drugmaker in Taiwan to find itself crosswise with regulators. In 2016, the FDA issued a warning letter to Taoyuan City-based Cheng Fong Chemical when inspectors found a foul-smelling, filthy plant with insects and layers of unidentified material on the floors of rooms that had never been cleaned. The letter said that among other problems, the plant had not been adequately investigating customer complaints of black particles in APIs.