MICROORGANISMS INCLUDE GRAM NEGATIVE BACTERIA, YEAST AND MOLDS On Monday, September 23, 2013 W.S. Badger Co. announced a voluntary recall of all lots of its 4-ounce Baby SPF 30 Sunscreen Lotion and one lot of its 4-ounce SPF Kids Sunscreen Lotion because of microbial contamination. The recall is being conducted with the knowledge of the U.S. food and Drug … [Read more...]
CDER GUIDANCES 2011– NEW/REVISED/WITHDRAWN
During 2011 CDER released a number of new Guidance for Industry documents. Many of these documents are quite difficult to locate within knowing the exact name of the document. These documents include the very widely publicized Process Validation (January 2011), several relating to PET (Positron Emission Tomography) products and their approvals, as well … [Read more...]
FDA’s Guidance for Industry Process Validation Issued Today
JUST RELEASED -- January 24, 2011 Guidance for Industry Process Validation: General Principles and Practices; Current Good Manufacturing Practices (CGMP), Rev 1. January 2011. Please contact: Barry A Friedman, PhD at barryafriedman@aol.com for a copy … [Read more...]
