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Gulf Pharmaceutical Industries (Julphar)

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Company: Gulf Pharmaceutical Industries (Julphar)
Plant: Ras Al Khaimah, UAE
Warning letter: Feb. 23, 2012

This warning letter, along with our tenth featured citation to Shamrock Medical Solutions Group, illustrates areas that manufacturers will probably need to give more consideration to: IT security and adequacy. With IT systems now the heart of manufacturing and record keeping, the agency wants to know that systems are robust enough to meet the needs and that only authorized users are accessing them.

In the case of Gulf Pharmaceutical Industries, the agency said it needed to update its system because it lacked the storage capacity to hold more than two years' worth of assay test results. The United Arab Emirates-based company also was not backing up some raw data, so a system failure would mean a data failure.