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...]
BAXTER HEALTHCARE CORP RECEIVES SINGLE WARNING LETTER FOR TWO LOCATIONS (05/31/13) — PART II
WHEN IS PARAMETRIC RELEASE USING TERMINAL STERILIZATION NOT STERILIZATION 3. "Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to … [Read more...]
FDA (CBER) ISSUES MULTI-NATIONAL WARNING LETTER TO SANOFI PASTEUR (07/12/12)
COMMENT The FDA published last Wednesday (July 25, 2012) a multipage Warning Letter to Sanofi Pasteur’s facilities in Toronto, Canada and Marcy l’Etoile, France. This Warning letter followed extensive GMP audits of both facilities between March 19 – April 2, 2012 (France) and April 10 and April 25, 2012 (Canada). Within the Warning Letter are issues relating to the … [Read more...]
