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FDA inspection passed

Date of event 3rd March 2011

An inspection of GMP compliance was conducted by the United States Food and Drug Administration from the 1st - 3rd March 2011. Laboratory facilities in Microbiology and Toxicology were inspected, data from sterility tests, bacterial endotoxin tests, tests for microbial examination of non-sterile products and pyrogen tests in support of two separate submissions were audited.

The quality of the data, the explanation of the processes and the openness with which the information was supplied were commended. The inspectors recommendation to CDER would be that the data was satisfactory and the submission will go ahead. The inspectors reviewed various investigation reports from 2009 and 2010. Investigation of OOS, change control, document control, training procedures and records and general Quality Management systems were all found to be satisfactory. One FDA 483 was received relating to 21 CR part 11 compliance, the finding was divided into 2 parts:- 1. The Endoscan V (BET) electronic record system does not track or record deletions of original electronic records from the file server. 2. Computer Security SOP does not instruct operators to log off or lock the computer work station when they leave an area. The Endoscan V data is printed and retained as a hard copy; discussions are underway with the vendor regarding 21 CFR part 11 compliance for the electronic data. The Computer Security SOP has been amended to include instruction for log-off.

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