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A July 10-20 FDA inspection of a Biocon manufacturing facility in Malaysia turned up eight observations including a repeat observation of failure to follow procedures that prevent microbiological contamination of drugs intended to be sterile, and inadequate review and investigation of failed batches. Read More
The FDA’s efforts to safeguard against the presence of diethylene glycol (DEG) ethylene glycol (EG) in drug products have resulted in the agency issuing 22 warning letters on the potentially lethal contaminant since March — and nine on the issue just this week. Read More
The FDA slapped Iso-Tex with a Form 483 following a Jan. 30 – Feb. 10 inspection because the radiopharmaceutical manufacturer failed to prevent microbiological contamination of drug products at its Alvin, Tex., plant. Read More
The FDA released a Form 483 from a May 4-12 inspection conducted at Catalent’s Bloomington, Ind., facility pointing to continuing woes for the plant and its customers, with observations of a lack of written production and process control procedures, inadequate equipment revalidation and inadequate cleaning. Read More
Multiple U.S. government agencies, in collaboration with India’s Directorate of Revenue intelligence, have stopped over 500 shipments of “illicit, and potentially dangerous, unapproved prescription drugs, combination medical devices, and synthetic drug precursors from reaching American consumers.” Read More
The FDA has updated how the Office of Pharmaceutical Quality (OPQ) will select manufacturing sites for routine surveillance inspection, using information about the compliance history of sites “to promote parity in inspectional coverage and the effective and efficient use of FDA resources to address the most significant public health risks.” Read More
A lack of conclusions or follow-up in written records of investigations into unexplained discrepancies since 2020 for Duopa Intestinal Gel (levodopa-carbidopa) prompted FDA investigators to issue a Form 483 to AbbVie’s North Chicago, Ill., facility following a Jan. 23-31 inspection. Read More
A June 22 FDA warning letter to API manufacturer Chengdu KeCheng Fine Chemicals details an October 2022 conversation in which the firm’s general manager told the FDA that his company was not shipping products to the U.S. Read More
Twenty-five drugs manufactured by Intas Pharmaceuticals have been excluded from an FDA import alert because they are in short supply, the agency wrote in a June 2 import alert letter, banning, however, all other drugs manufactured at the company’s Sanand, India, facility. Read More