NEPHRON PHARMACEUTICALS APPLAUDED FOR PROACTIVE STANCE Nephron Pharmaceuticals Corporation, Orlando, FL (NPC) recalled 689,568 cartons (ten lots) of Albuterol Sulfate Inhalation Solution for oral inhalation. The recall, which was initiated by the firm and was voluntary, was caused by a “Lack of Assurance of Sterility: … [Read more...]
NEW DRUG MICROBIOLOGY STAFF MEMBER PRESENTS INFORMATION ON ON-GOING PILOT PROGRAM
PROGRAM INCLUDES THE REVIEW OF NON-STERILE PRODUCTS John W. Metcalfe, Ph.D., of the New Drug Microbiology Staff at CDER gave an excellent, informative presentation on “Regulatory Review Perspectives for Non-Sterile Drug Products” at the PDA Global Microbiology Conference on Monday, October 21, 2013 in Bethesda, MD. This presentation presented information on a Pilot Program … [Read more...]
ANOTHER INDIAN FACILITY RECEIVES WARNING LETTER FOR POOR ASEPTIC PROCESSING
FDA QUESTIONS FIRM’S BASIC UNDERSTANDING AND MICROBIAL CONTROLS CRITICAL FOR THE MANUFACTURE OF STERILE PRODUCTS Agila Specialties Private Ltd, located at Bommasandra Jigani Link Rd., Bangalore, India was audited by the FDA from June 17 to June 27, 2013. The audit resulted in the FDA continuing to consider their Import Hold on this facility. Significant Observations included … [Read more...]
FIRM RECALLS SUNSCREEN LOTIONS FOLLOWING RETESTING
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...]
TESTING LABORATORY RECEIVES STERILITY OBSERVATIONS
FDA FINDS LABORATORY CONDUCTING STERILITY AND ENDOTOXIN TESTING FOR COMPOUNDING CENTERS HAS SIGNIFICANT ISSUES WITH STERILITY ASSURANCE The FDA recently audited Front Range Laboratories, Loveland, CO from August 5 through August 30, 2013. Their five investigators issued a five Observation, twelve page document. Enclosed is Observation 1 which … [Read more...]
