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...]
INTERNATIONAL LABORATORIES (CANADA) LTD RECEIVES FDA (CDER) WARNING LETTER (10/23/12)
NO FDA EXPORT BAN (REFUSAL OF ADMISSION) IS ISSUED The FDA conducted an inspection of International Laboratories from February 13 – 16, 2012 at their facilities in Calgary, Alberta. While the Company responded within 15 business days, the responses to the audit were unsatisfactory and a Warning Letter containing five Observations was … [Read more...]
IMPORT ALERT FINDING GREATER USAGE WITHIN FDA’S BAG OF “WEAPONS”
GULF PHARMACEUTICAL INDUSTRIES (02/23/12), NOBILUS ENT (03/07/12) and LABORATORIOS JALOMA S.A. de C.V. (03/9/12) ALL RECEIVE IMPORT ALERTS WITHIN ONE MONTH AS PART OF THEIR WARNING LETTERS The FDA has recently begun to use within their CDER Warning Letters the following terminology on a frequent basis. This includes … [Read more...]
GULF PHARMACEUTICAL INDUSTRIES RECEIVES WARNING LETTER (2/23/12) RELATED TO ASEPTIC PROCESSING
TWO STRIKES AND YOU’RE OUT -- GULF PHARMA REMAINS UNDER FDA IMPORT ALERT. Gulf Pharmaceutical Industries was audited between September 25 and October 3, 2011. During this inspection, the FDA found significant violations related to aseptic processing. Several of these violations were a repetition of violations observed during a … [Read more...]
