The FDA has come down on a drugmaker in Kingston, Jamaica, that it says is coming up short in manufacturing standards and ensuring sterility.
The FDA said that Benjamin Manufacturing should consider hiring a consultant that could help its bring standards up and revamp its quality assurance. The warning letter lists a number of observations made during last year's inspection. They include the fact that the company was not testing for microbial contamination either during manufacturing or once products were finished. It said maintenance and cleaning of equipment was also not up to par.
Benjamin had been releasing products for distribution in the U.S. without investigating batch failures. The quality assurance manager's contention that specification failures would have no bearing on "therapeutic activity of the drug products" swayed no one at the agency. The company had no formal procedures for validating strength and quality and reprocessed several batches without even notifying the quality assurance group. As for its quality assurance unit, the letter said, it often released product without reviewing "multiple corrections of documentation errors."
Read more: FDA lambastes Jamaican manufacturer over sterility, quality - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-lambasts-jamaican-manufacturer-over-sterility-quality/2013-02-16#ixzz2LPQhBSEA
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