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Citing data integrity concerns, the FDA hit Kyowa Hakka Bio with another warning letter for repeat violations at its Hofu, Yamaguchi facility. The agency issued a previous warning to the facility in 2010. Read More
The FDA cited API manufacturer Shandong Zouping Dazhan New Materials after a January inspection of the firm’s Shandong facility revealed significant testing and other violations. Read More
The FDA shot Signature Formulations a warning letter arising from an October inspection of the manufacturer’s Phoenix, AZ, facility that revealed cleaning and maintenance deficiencies and failure to test products and ingredients for conformance. Read More
The FDA sent a warning letter to Apotex Research after discovering significant and repeat violations at its Bangalore facility that led to adulterated finished drug products. Read More
The FDA issued a warning letter to an API manufacturing facility in Yicheng City, Hubei, based on a September 2017 inspection that found many repeat violations including a lack of validation studies and adequate API analysis. Read More
The FDA issued a warning letter to an API manufacturing facility in Yicheng City, Hubei, based on a September 2017 inspection that found many repeat violations including a lack of validation studies and adequate API analysis. Read More
The firm attributed out-of-specification and out-of-trend assay results for certain tablets to sampling preparation errors but didn’t provide any evidence to support the findings. Read More
The FDA sent a warning letter to Apotex Research after discovering significant and repeat violations at its Bangalore facility that led to adulterated finished drug products. Read More
On several occasions after removing jams the operator leaned inside the restricted access barrier system to clean the equipment, the agency said. Read More