FDA warns Span­ish drug and API man­u­fac­tur­er over mul­ti­ple pro­duc­tion line prob­lems

The FDA de­liv­ered a laun­dry list of cit­ed prob­lems to a Eu­ro­pean man­u­fac­tur­er with pro­duc­tion line is­sues that in­clud­ed mi­cro­bi­o­log­i­cal con­t­a­m­i­na­tion and im­prop­er clean­ing pro­ce­dures. The Form 483 was sent to Span­ish drug ma­te­ri­als man­u­fac­tur­er Bioiber­i­ca’s ma­te­ri­als man­u­fac­tur­ing plant in Palafolls, north of Barcelona.

In an in­spec­tion be­tween Jan. 31 and Feb. 4 this year the FDA found that clean­ing pro­ce­dures for the equip­ment used in the drug sub­stance man­u­fac­tur­ing were not val­i­dat­ed as nec­es­sary to en­sure ad­e­quate clean­ing and con­t­a­m­i­na­tion pre­ven­tion mea­sure. The FDA al­so found mi­cro­bi­o­log­i­cal con­t­a­m­i­na­tion and a lack of es­tab­lished con­trol pro­ce­dures to mon­i­tor the out­put man­u­fac­tur­ing process­es that could po­ten­tial­ly cause vari­abil­i­ty in the drug sub­stance.

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