FDA hits New Jersey API manufacturer with 14 deficiencies across three sites in Form 483

Spec­trum Lab­o­ra­to­ry Prod­ucts is the lat­est API man­u­fac­tur­er to re­ceive an FDA Form 483 fol­low­ing an in­spec­tion. The 483 in­cludes 14 de­fi­cien­cies from sev­en in­spec­tions be­tween Feb­ru­ary and March of this year.

The 13-page doc­u­ment, pub­lished Oc­to­ber 5, de­tails how the FDA car­ried out four in­spec­tions at the API man­u­fac­tur­er be­tween Feb­ru­ary 8 and 24, and three in­spec­tions were car­ried out on March 6, 15 and 24.

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.