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A Lupin Pharmaceuticals facility in Somerset, N.J., has received a 38-page Form 483 with more than a dozen observations following a Sept. 10-Nov. 5, 2020, inspection by the FDA. The FDA’s options at this point are to do another inspection or to take regulatory action, such as a warning letter to the company. Read More
Representatives of generic drugmakers put forward several ideas for the FDA to consider for manufacturing facility inspections during a January meeting to discuss the agency’s commitments as part of the reauthorization of the Generic Drug User Fee Act (GDUFA). Read More
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