Scoop: Re­silience re­ceives Form 483 due to mold at Cana­di­an site, more lay­offs an­tic­i­pat­ed

Na­tion­al Re­silience was hand­ed a Form 483 in No­vem­ber not­ing that the man­u­fac­tur­er did not prop­er­ly re­view or ad­dress mold-con­t­a­m­i­nat­ed prod­uct batch­es, and it may un­der­go more lay­offs this year, a source fa­mil­iar with the mat­ter told End­points News.

The Nov. 10 form states that Re­silience’s in­ves­ti­ga­tions of the con­t­a­m­i­nat­ed batch­es, which start­ed in 2021, “failed to eval­u­ate all as­pects.” De­spite claim­ing that cer­tain ac­tive in­gre­di­ent batch­es were pri­mar­i­ly re­spon­si­ble for the con­t­a­m­i­na­tion, the man­u­fac­tur­er didn’t go on to test these batch­es to con­firm its be­lief, ac­cord­ing to a copy of the form ob­tained by End­points.

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