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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