FDA says Ipca Labs failed to address quality issues with bad API batches

Ip­ca Lab­o­ra­to­ries, an In­dia-based mak­er of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents, was cit­ed for sev­er­al qual­i­ty and test­ing is­sues dur­ing a re­cent FDA in­spec­tion.

The FDA in­spect­ed an Ip­ca man­u­fac­tur­ing fa­cil­i­ty in Rat­lam, In­dia, be­tween June 5 and June 13, and in­ves­ti­ga­tors made a to­tal of 11 ob­ser­va­tions.

The FDA said the com­pa­ny failed to prop­er­ly in­ves­ti­gate root caus­es for de­fi­cient API batch­es. In April, Ip­ca had re­ceived a com­plaint say­ing there were “met­al-like par­ti­cles and mag­net par­ti­cles” in some prod­ucts. The reg­u­la­tor al­so said the fa­cil­i­ty’s qual­i­ty unit did not is­sue a re­call of an un­named prod­uct that did not meet spe­cif­ic im­pu­ri­ty stan­dards.

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