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A Janssen production plant that turned heads for its continuous production line was handed a 483 two months prior to switching the line from batch production. Read More
Two compounders are facing FDA warning letters for sterility concerns, with one company being pummeled for numerous other quality deficiencies. Read More
Two foreign API makers have landed FDA warning letters accusing them of violations ranging from data falsification to finished product deficiencies. Read More
The FDA is calling out two dietary supplement makers for a host of issues, including drug-like promotional claims and GMP issues that render their products adulterated. Read More
Two compounding operations are facing FDA allegations of producing adulterated drugs and doing so without prescriptions following agency inspections. Read More
UK regulators have fined Pfizer $14,000 for failing to explain a questionable claim meant to justify price increases on the generic seizure medication Epanutin. Read More