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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER