FDA Inspectors = Sherlock Holmes: FDA Inspector to Find Major Issues with GMP Compliance by Paying Close Attention to Details
Posted on: Thursday, July 2, 2015
Some Warning Letters demonstrate that quality of training of FDA Inspectors. FDA Inspectors are trained to pay close attention to seemingly minor observations to catch errant manufacturers. Recently, in a Warning Letter issued to a manufacturer of oxygen tanks, Trans Ox located at West Columbia, South Carolina, FDA inspectors identified several discrepancies in documents and gross violations of GMP regulations. It is not the findings but how FDA detected them that is of interest. In one case, the manufacturer had documented that a portable oxygen analyzer was used to conduct a critical release test, however, FDA inspector noted that between the wall on which the portable oxygen analyzer was hung and the device, there were cobwebs, indicating that the device was never removed from its location. How could a device be used to conduct testing if it was never removed from its location, FDA asked. On being caught red-handed at lying the responsible person confessed that the device was never used for testing. Similarly, the FDA inspector observed that multiple batch records contained identical test results. Again it was found that the manufacturer simply filled the results on the batch records without ever conducting tests. The responsible personnel at the facility were not even aware of basic GMP terminology and lacked training in documentation and SOPs. The most amazing part of this story for me is that despite all these findings the FDA has not yet shut down the facility but given them time to address the findings or face closure. One thing should be clear to all regulated organization, FDA auditors pay attention to the slightest of observations and can catch you at your lie. It is very important that every personnel at a given facility be trained in applicable regulations such as GMP for manufacturing sites, GCP for clinical sites, and GLP for testing laboratories. It is also important that facilities maintain a high level of quality control and quality assurance standards. With so many training opportunities available these days, lack of training is inexcusable.
Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research