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."
On top of that, it said that health claims made on labels for a whole list of its OTC products would qualify them as prescription drugs, and for that they are unapproved. Some of them, it said, did not meet OTC standards.
Generic drugmakers are now paying user fees to the FDA and some of that money is helping the agency pick up the pace of inspections of foreign plants. FDA Commissioner Margaret Hamburg last week made reference to its growing global operations in a response to a FDA-funded report calling for international drug standards for manufacturing and oversight. She said the agency now has a presence in 12 countries in 7 regions. The FDA, she said, is "transforming from a predominantly domestically focused agency to one that is fully prepared to help ensure product safety and quality within a globalized world."
- read the warning letter