internet Marketing Cited in FDA Warning Letter
“The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your website, http://www.depuyorthopaedics.com. for the TruMatch™ Personalized Solutions System and the Corail® Hip System.”
Read the Warning Letter to DePuy
View J&J’s Current Webpage on Hip Replacements
UPDATE: J&J is not the only company in hot water with FDA for marketing. Forest Laboratories has agreed to a $300 Million settlement for the following: “Forest Pharmaceuticals, Inc. entered into a plea agreement in which the company accepted responsibility for criminal actions including distribution of an unapproved new drug, distribution of a misbranded drug, and obstruction of an FDA inspection.”
FDA Press Release on Forest Labs
Read “J&J’s Quality Control Headaches”
On The Blogroll: Again, I would like to highlight some of the blogs found on the blogroll to the right. This blog focuses on public health, The Pump Handle.
Save The Date: On 4-5 November 2010 the Pacific Regional Chapter of the Society for Quality Assurance (PRCSQA) and the Organization of Regulatory and Clinical Associates (ORCA), a Pacific Northwest based organization, will co-sponsor a Fall Training on regulatory compliance topics in Seattle, WA.
The PRCSQA LinkedIn Group will update the agenda for the training. PRCSQA Fall Training workshops have traditionally been “at cost” and are an affordable training opportunity. The sessions will cover both GCPs and GLPs with speakers lined up on vendor management, quality systems, and GLP updates.
In news from GxP Perspectives read the updated article on the Form FDA 1572 in:
Applied Clinical Trials “Closing Thought” on FDA 1572
ALSO: Please join me on LinkedIn at:
GxP Perspectives LinkedIn Group
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