Over the past several years the FDA has issued Warning Letters to a number of aseptic processing facilities that have encountered difficulties with their management of air flow. While the management of airflow appears to be an easy area to manage within the Aseptic Processing Area (APA), the number of Warning Letters (Click Here) has suggested otherwise. The … [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...]
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...]
