FDA slaps Flori­da's Al­lay Phar­ma­ceu­ti­cals with warn­ing let­ter over vague re­spons­es to drug po­ten­cy is­sues

In­ad­e­quate re­spons­es to find­ings of po­ten­cy dis­crep­an­cies, blend­ing is­sues and out-of-spec­i­fi­ca­tion sam­ples dur­ing a May 2020 in­spec­tion re­cent­ly land­ed tablet man­u­fac­tur­er Al­lay Phar­ma­ceu­ti­cals with a scorch­ing FDA warn­ing let­ter.

In a heav­i­ly-redact­ed ver­sion of the Jan 27 let­ter that was made avail­able this week, the FDA chid­ed the Hialeah, Flori­da man­u­fac­tur­er for vague and in­suf­fi­cient re­spons­es across the board to three ma­jor ob­ser­va­tions dis­cov­ered dur­ing the May 5 to 15, 2020 site in­spec­tion. Those ob­ser­va­tions were com­mu­ni­cat­ed through a Form 483 let­ter, and Al­lay’s re­spons­es to the FDA on June 6 clear­ly irked the agency.

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