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The FDA is using a temporary process during the pandemic for communicating issues it finds after reviewing records or other information requested in lieu of or in advance of pre-approval or pre-license inspections for Center for Drug Evaluation and Research (CDER)-regulated products. Read More
Eywa Pharma’s generic drug manufacturing facility in Cranbury, N.J., drew a Form 483 from the FDA for quality deficiencies observed during an agency inspection. Read More
The FDA called on drug compounders to know their active pharmaceutical ingredient (API) suppliers as it issued a warning letter to Houston, Texas-based Professional Compounding Centers of America (PCCA) for using a supplier whose drug ingredients had been placed on an import alert. Read More
Yuyao YiJia Daily Chemical, an over-the-counter drug manufacturer in Ningbo, China, drew a warning letter from the FDA for not adequately testing its products, their active ingredients and the raw materials used to manufacture them. Read More
The FDA issued a Form 483 with five observations to a Maryland-based sterile drug manufacturer, Pharmaceutics International, after an Oct. 19-30 inspection. Read More
The FDA called on drug compounders to know their active pharmaceutical ingredient (API) suppliers as it issued a warning letter to Houston, Texas-based Professional Compounding Centers of America (PCCA) for using a supplier whose drug ingredients had been placed on an import alert. Read More
Yuyao YiJia Daily Chemical, an over-the-counter drug manufacturer in Ningbo, China, drew a warning letter from the FDA for not adequately testing its products, their active ingredients and the raw materials used to manufacture them. Read More
Over-the-counter drugmaker US Pharmaceuticals of Belleville, N.J. drew a Form 483 from the FDA with four observations following an Oct. 6-16, 2020 inspection. Read More
FDA investigators observed multiple deficiencies during an October 2020 inspection of B. Braun Medical’s sterile IV fluids facility in Daytona Beach, Florida. Read More
Ascent Pharmaceuticals, a drug manufacturer in Central Islip, New York, drew a Form 483 after the FDA observed deficiencies at its facility, including a failure to check the effectiveness of corrective and preventive actions (CAPAs). Read More
FDA inspections revealed good manufacturing practice and other deficiencies at drug manufacturing facilities in New Jersey, Vermont and California, leading to Form 483 inspection observations for four firms. Read More