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The FDA has issued a Form 483 to Advanced Accelerator Applications, citing quality and laboratory control issues observed during an inspection of the company’s sterile drug manufacturing facility in Millburn, N.J. Read More
Agropharma Laboratories of Salinas, Puerto Rico, has received a three-observation Form 483 citing issues with laboratory controls, cleanliness of the facility and quality control. Read More
An FDA investigator observed that Belport, a drugmaker in Camarillo, Calif., doing business as Gingi-Pak, didn’t conduct microbiological testing of the water used to manufacture its drug products, among other quality lapses noted during a Nov. 8 to 12, 2021, inspection of its facility. Read More
FDA investigators observed many weaknesses in current good manufacturing practice (cGMP) procedures, among other quality lapses, during an inspection of Janssen’s drug manufacturing facility in Gurabo, Puerto Rico. Read More
Drugmaker Catalent Massachusetts drew a Form 483 with four observations following an FDA inspection of its Chelsea, Mass., drug manufacturing facility. Read More
The FDA has sent Mumbai-based Macleods Pharmaceuticals a 19-page, seven-observation Form 483 outlining many issues related to the cleanliness of its manufacturing facility after an inspection in October and November of 2021. Read More
An FDA remote inspection can carry major drawbacks, including that they may last longer than an in-person visit and that the FDA doesn’t consider them to be a full substitute for an on-site inspection. Read More
An FDA inspection of Regeneron Pharmaceuticals’ active pharmaceutical ingredient (API) manufacturing facility in Rensselaer, N.Y., turned up observations of lapses in recordkeeping and cleaning procedures. Read More
The FDA is not ruling out further use of remote assessments for Good Clinical Practice (GCP) inspections postpandemic, but the agency is clear: the bulk of its inspection activity will remain onsite despite more remote-based approaches catching on elsewhere. Read More
The FDA has issued a warning letter to Indiana Chem-Port, an active pharmaceutical ingredient (API) manufacturer in Gujarat, India, for significant deviations from current good manufacturing (GMP) practices, rendering its products adulterated. Read More
The FDA has issued a warning letter to Innoveix Pharmaceuticals arising from an inspection of the company’s drug compounding facility in Addison, Texas, last May in which an agency official observed serious deficiencies in the plant’s sterile production practices. Read More
FDA investigators observed faulty HEPA filters close to products being manufactured and other quality lapses at Catalent’s Brussels drug facility during an October 2021 inspection. Read More