Up­dat­ed: Span­ish he­parin man­u­fac­tur­er draws the ire of the FDA in its lat­est warn­ing over qual­i­ty con­cerns

Span­ish he­parin and API man­u­fac­tur­er Bioiber­i­ca is still not in the clear as far as the FDA is con­cerned, with a new warn­ing let­ter re­lat­ed to con­t­a­m­i­na­tion con­cerns.

The US reg­u­la­tor ini­tial­ly is­sued a Form 483 to the Span­ish drug­mak­er’s man­u­fac­tur­ing plant in Palafolls, north of Barcelona.

In an FDA in­spec­tion be­tween Jan. 31 and Feb. 4 this year, the reg­u­la­tor found sev­er­al ma­jor is­sues re­lat­ed to clean­ing and con­t­a­m­i­na­tion and a lack of con­trol pro­ce­dures among oth­er ob­ser­va­tions. The agency has now is­sued a warn­ing let­ter con­cern­ing sig­nif­i­cant de­vi­a­tions in cGMP for ac­tive APIs at the fa­cil­i­ty.

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