Warn­ing let­ter is­sued to New Jer­sey gener­ics man­u­fac­tur­er over qual­i­ty con­trol is­sues

A gener­ics man­u­fac­tur­er has re­ceived a warn­ing let­ter from the FDA over sev­er­al is­sues sur­round­ing su­per­vi­sion and qual­i­ty con­trol.

Bi-Coastal Phar­ma In­ter­na­tion­al’s drug man­u­fac­tur­ing fa­cil­i­ty in Shrews­bury, New Jer­sey ini­tial­ly re­ceived a Form 483 ear­li­er this year. But ac­cord­ing to an­oth­er let­ter dat­ed June 30, the FDA has found some fla­grant is­sues with the com­pa­ny’s re­spons­es.

The let­ter ini­tial­ly stat­ed that Bi-Coastal had failed to es­tab­lish and fol­low writ­ten pro­ce­dures around the han­dling of writ­ten and oral com­plaints for drug prod­ucts.

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