FIRM FAILS TO ASSURE ADEQUATE USE OF SPORICIDAL AGENTS AND CLEANING SUPPLIES Jubilant HollisterStier, Spokane, WA was audited by the FDA between April 15 and May 10, 2013. The FDA reviewed the firm’s response from May 30 and noted that sufficient corrections actions were lacking. The FDA also received additional correspondence dated July 12 and August 15, but believed that a … [Read more...]
JUBILANT HOLLISTERSTIER, LLC RECEIVES WARNING LETTER (11/27/13)
FIRM FAILS TO PERFORM MEDIA FILL PROCESS SIMULATIONS FOLLOWING MAJOR RENOVATION Jubilant HollisterStier, Spokane, WA was audited by the FDA between April 15 and May 10, 2013. The FDA reviewed the firm’s response from May 30 and noted that sufficient corrections actions were lacking. The FDA also received additional correspondence … [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...]
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...]
