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Belcher Pharmaceuticals received a Form 483 from the FDA for several deficiencies observed during a Nov. 1- 15, 2021, inspection of its drug manufacturing facility in Largo, Fla. Read More
Baxter Pharmaceuticals Solutions’ contract manufacturing facility in Bloomington, Ind., has received a Form 483 for several deficiencies observed during an FDA inspection from Nov. 2 through Nov. 10, 2021. Read More
Drug compounding pharmacy Ideal Specialty Apothecary of Parsippany, N.J., has received a Form 483 detailing quality deficiencies observed during an FDA inspection from Sept. 13 through Nov. 18, 2021. Read More
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