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.

Most no­tably, the FDA took is­sue with the fact that Al­lay ei­ther doesn’t have, or didn’t pro­vide, suf­fi­cient da­ta that could ex­plain why the tablet sam­ples of an un­named drug that were tak­en dur­ing the site in­spec­tion last year were be­low nec­es­sary po­ten­cy stan­dards and var­ied in what po­ten­cy they had.

“Your man­u­fac­tur­ing fail­ures in­di­cate that you do not have an ad­e­quate on­go­ing pro­gram for mon­i­tor­ing process con­trol to en­sure sta­ble man­u­fac­tur­ing op­er­a­tions and con­sis­tent drug qual­i­ty,” the FDA wrote, lat­er urg­ing the com­pa­ny to con­sult with a cGMP ex­pert to bring its stan­dards up to code.

While it’s un­clear ex­act­ly how many drugs the FDA ob­ser­va­tions are re­lat­ed to, Al­lay is un­der con­tract to pro­duce at least one tablet with a com­pa­ny whose name is al­so redact­ed. Re­gard­less of what oth­er terms the two groups agreed to, the FDA made clear to Al­lay that it is re­spon­si­ble for meet­ing qual­i­ty stan­dards, which it hasn’t done or in­ves­ti­gat­ed in a thor­ough man­ner.

“In the qual­i­ty agree­ment with the prod­uct own­er, you have the pri­ma­ry re­spon­si­bil­i­ty for in­ves­ti­gat­ing (out-of-spec­i­fi­ca­tion) re­sults,” the let­ter reads. “Your in­ves­ti­ga­tion in­to the OOS sam­ple re­sult was in­ad­e­quate and did not iden­ti­fy (Cor­rec­tive Ac­tion and Pre­ven­tive Ac­tion). Fur­ther­more, an in­ves­ti­ga­tion was not per­formed to en­sure that pre­vi­ous­ly re­leased lots met your re­vised as­say spec­i­fi­ca­tions. FDA in­ves­ti­ga­tors found 13 lots with­in ex­piry that ex­ceed­ed your new as­say spec­i­fi­ca­tion dur­ing re­lease or sta­bil­i­ty test­ing. These lots should have been iden­ti­fied in your in­ves­ti­ga­tion.”

The FDA al­so high­light­ed test­ing er­rors and dis­crep­an­cies for ac­tive phar­ma­ceu­ti­cal in­gre­di­ents, call­ing out test­ing re­sults that didn’t match up to those quot­ed by a new API man­u­fac­tur­er used by Al­lay. In one in­stance, the com­pa­ny’s tests on an API lot dif­fered by 7.8% com­pared to the rate quot­ed by the in­gre­di­ent mak­er, but Al­lay went ahead with man­u­fac­tur­ing its drug any­way, the FDA said.

Al­lay is now re­quired to pro­vide the FDA with a re­view of all oth­er prod­ucts it man­u­fac­tures, re­gard­less of whether the prod­ucts were iden­ti­fied in the Form 483 ob­ser­va­tions, as well as a “com­pre­hen­sive and in­de­pen­dent” as­sess­ment es­sen­tial­ly of its en­tire sys­tem for ad­dress­ing de­vi­a­tions from cGMP man­u­fac­tur­ing process­es.

Al­lay has 15 busi­ness days (Feb. 18) to re­spond to the FDA’s warn­ing let­ter. The com­pa­ny did not im­me­di­ate­ly re­turn a re­quest from End­points News seek­ing com­ment.

Jazz CEO Bruce Cozadd didn’t beat around the bush.

In his first video meeting with GW Pharma chief Justin Gover last July 8, he offered to pay $172 a share to get the company, which had beaten the odds in getting its remarkable cannabinoid drug Epidiolex across the regulatory finish line for epilepsy. GW’s stock closed at $129 that day.

Cozadd had already done his homework on the financing to make sure he could swing it the way he wanted. He just needed to do some due diligence before making the non-binding bid firm.