FDA warns Sure-BioChem over quality and data issues
A warning letter has been given to a company that tests finished drug products over several quality issues.
The FDA issued the warning letter to Sure-BioChem Laboratories, a Camden, NJ-based contract test laboratory that does microbial testing on products including finished drugs. Sure-BioChem was inspected late last year, but the regulator has advised the company that it still needs to make some corrections.
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