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SFDA probes contaminated drugs from Gulf firm
Published in The Saudi Gazette on 18 - 03 - 2012

The Saudi Food and Drug Authority (SFDA) has launched a probe into the safety of certain drugs manufactured by a pharmaceutical company headquartered in the United Arab Emirates (UAE).
This comes after the SFDA received a warning from the American Food and Drug Authority (FDA), on its website, that some of the contaminated drugs had entered the United States, it was reported by a section of the Arabic press on Friday. The newspaper said it was withholding the name of the company.
The American FDA had, during an inspection of the factory, found that the company was not following sterilization standards on one of its production lines for intravenous medicines. There was a threat of the drugs being contaminated with bacteria.
The warning message specified only one of the production lines for injections and not the other medicines of the company.
The FDA inspectors discovered that there was a lack of written guidelines for some of the manufacturing processes and the absence of advanced electronic systems to prevent changes being made by unauthorized persons in the production line procedures.
The SFDA source, requesting anonymity, said Thursday that such warning messages are normal among monitoring and supervisory authorities and are taken seriously. Investigations take place at the source to determine the credibility of the warnings.
“The Saudi Food and Drug Authority is coordinating with the supervisory authority in the UAE and the Central Committee for Registering Medicines to take the necessary measures.”
Informed sources said the SFDA receives reports from pharmacists, doctors and citizens regarding the quality of marketed medicines. Forms for this purpose are available on the SFDA website. The authority scrutinizes the information on the forms and takes the necessary measures.


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