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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
FDA investigators handed Novartis Farma SpA a Form 483 after finding documents missing information about equipment calibration, verification testing and software deviations. Read More
The best organizations use findings from both internal audits and third-party inspections to build knowledge for future improvement — using audit data to improve the audit program itself, says Steven Lynn, executive vice president of pharmaceuticals at Regulatory Compliance Associates. Read More
Pharmedica USA’s Phoenix, Ariz., drug manufacturing facility was cited by the FDA in a warning letter for lack of a sterile environment for producing its OTC eye drops and for having a manufacturing facility that “was in a state of disrepair.” Read More
Multiple unaddressed violations of current good manufacturing practice, FDA regulations and noncompliance with a 2012 consent decree have earned India’s Sun Pharmaceutical a hefty list of corrective actions to complete before resuming drug exports to the U.S. Read More