FIRM FALSIFIES MICROBIAL DATA Canton Laboratories, India was found to have reported analytical results without having performed the testing. C of A’s stated that the data conformed to specifications; however, multiple personnel confirmed that the testing was not performed. Similar data was observed in July 2008 with other testing. Please read below to learn more about … [Read more...]
JUBILANT HOLLISTERSTIER, LLC RECEIVES WARNING LETTER (11/27/13)
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...]
Wockhardt’s Walui and Chikalthana Facilities, Maharasthtra Receive Warning Letter (11/25/13)
Data Manipulation Continues to be a Major Issue After a somewhat quiet month, CDER is again active in India. Their current concern is with a Company that should be familiar to each of us. And the issues in many cases are similar to those found within a Warning Letter issued in July of this year. Alexander Gaffney, RAPS Editor, has put together an excellent summary of this … [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...]
