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Compounding pharmacy Kelley-Ross & Associates in Seattle drew a warning letter from the FDA after an agency inspection in July found numerous sanitation violations. Read More
The FDA called out Indian API manufacturer Vamsi Labs for failing to complete investigations at its Solapur, Maharashtra facility, including one for API batches shipped to the U.S. Read More
The firm “did not collect microbiological water samples prior to cleaning the system when the previously scheduled sanitation cycle was not run,” the agency said. Read More
The FDA called out Indian API manufacturer Vamsi Labs for failing to complete investigations at its Solapur, Maharashtra facility, including one of API batches shipped to the U.S. Read More
Compounding pharmacy Kelley-Ross & Associates in Seattle drew a warning letter from the FDA after an agency inspection in July found numerous sanitation violations. Read More
The FDA cited ADMA Biologics for failure to implement proper document controls and prevent unauthorized changes to data in its computer systems. Read More
The FDA rapped finished drugmaker Higiene + Salud for shoddy recordkeeping and deficient investigations after a November inspection of the company’s Toluca, Mexico facility. Read More
Citing data integrity concerns, the FDA hit Kyowa Hakka Bio with a 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 issued a warning letter to Hangzhou Karic Commodities and placed it on an import alert after an inspection of its Hangzhou, Zhejiang facility revealed numerous violations, including a failure to test batches for conformity prior to release. Read More