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A Baxter Healthcare drug manufacturing plant in Marion, N.C., has been hit with another Form 483 after an FDA inspection early in the year revealed more deficiencies, including two that remain unresolved from prior inspections. Read More
This Q and A is from the management report titled “Managing Data and Documentation for FDA Inspections and Remote Assessments,” based on a webinar from FDAnews, A WCG Company. The presenter was David Chesney, a former director of the FDA’s San Francisco District Office who is now principal and general manager of DL Chesney Consulting. Read More
Brassica Pharma, a maker of sterile semi-solids, received an FDA Warning Letter for failure to test every batch for sterility as well as fabrication of test results for batches not tested, among other violations. Read More
In this edition of Quick Notes, we cover a workshop on psychedelics, regulations on substances of human origin, selection of the COVID-19 strain for the next vaccines and a 483 for Swiss company Lonza. Read More
The FDA significantly increased foreign inspections in fiscal 2023 while domestic inspections remained flat, according to the agency’s latest annual inspection report. Read More
Following a Form 483 inspection report that Jiangsu Hengrui Pharmaceuticals of China was found to be storing sterile injectable drugs bound for the US market on corroded metal racks which themselves stood in pools of water dripping from black mold-covered condensation pipes, the company has now received an FDA Warning Letter. Read More
The FDA has called out three drugmakers for lack of compliance with current good manufacturing practices (cGMP) and marketing unapproved products, among other lapses. Read More
Multiple and repeated violations found in Sun Pharmaceuticals’ Dadra, India facility during a December 2023 FDA inspection have resulted in a Warning Letter following the company’s inadequate responses to a Form 483 levied on it earlier this year. Read More
An Indian plant that makes a number of drugs and active pharmaceutical ingredients (API) was socked with a six-observation Form 483 noting multiple problems with validation testing for API and drug batches, as well as the validation tests themselves. Read More
Finding troubling irregularities in their analysis of FDA’s foreign drug manufacturer inspections, House Energy and Commerce Republicans are pressing the agency for answers. Read More