FDA cites Gulf Pharmaceutical for predating documentation

The FDA has raised serious concerns about the manufacturing and data security processes at a plant in the United Arab Emirates operated by Gulf Pharmaceutical Industries.

In a warning letter issued Feb. 23 and posted on the FDA website today, the agency said the company had been predating "Manufacturing Document Compliance Declaration forms." Investigators also noted that Gulf had misleading dating practices concerning reports used to document personnel practices in the aseptic filling area during filling operations at the plant in Ras Al Khaimah.

"The lack of reliability and accuracy of data generated by your firm is a serious CGMP deficiency that raises concerns with all data generated by your firm," the letter said. The letter also said the company's plan to investigate only the records listed in a 483 report was insufficient. The FDA ordered the company to review "the analytical data and batch records for all products manufactured at your facility that remain within expiration."

In other concerns, the FDA said the company's computer system was inadequate to maintain all of the needed data, that there were no electronic files on raw data for most HPLC assays older than two years because space is limited and data is deleted to make space for more recent test results. Printed copies also do not contain all of the analytical metadata. The FDA did note that the company was instituting a plan for more complete data backup.

The FDA also raised questions about testing gowns for sterility and also noted that the company was not doing sufficient airflow pattern studies for the ampoule filling line used for the production of medications distributed to the U.S.

- here's the warning letter

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