We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA issued a Sept. 22 warning letter to devicemaker Daavlin Distribution following an inspection that revealed numerous deficiencies, ranging from management shortcoming to inadequate quality audits.
Drug and device companies need to understand that their responses to Form 483 observations can affect the FDA's perception of an entire firm's operations, according to a consultant who specializes in the area.
FDA investigators gave a clean bill of health last week to Boston Scientific’s Galway, Ireland, plant, one of two manufacturing sites responsible for producing faulty Taxus stent systems that resulted in several high-profile product recalls.
Diagnostics manufacturer BioMerieux was recently slapped with an FDA warning letter documenting at least 10 violations of current good manufacturing practices (cGMPs).
Continuing a recent enforcement trend, the FDA last week published three new warning letters addressed to clinical trial operators.
The agency has issued a plethora of warnings to clinical investigators in recent months as part of an effort to crackdown on violations at universities and other research sites.
The FDA's highly anticipated third-party inspection program is taking longer to get off the ground than expected, largely due to a lack of funding to train the inspectors who will participate in the program, industry sources report.
The Nuclear Regulatory Commission (NRC) has dispatched an inspection team to a Baxter Healthcare manufacturing plant to investigate an incident in which two workers were exposed to radiation.
The FDA recently issued warning letters to two Asian manufacturers found to be in violation of current good manufacturing practice (cGMP) requirements.
Roche stated last week that it has completed the integration of troubled Disetronic Medical Systems into its operations and is making preparations for an FDA re-audit to resolve good manufacturing practices (GMP) deficiencies discovered within the subsidiary.