Biocon facility in Malaysia found to have issues once again by the FDA

A re­cent FDA in­spec­tion of a Bio­con man­u­fac­tur­ing fa­cil­i­ty in Malaysia has re­vealed more is­sues re­lat­ing to clean­li­ness.

The reg­u­la­tor in­spect­ed Bio­con’s man­u­fac­tur­ing fa­cil­i­ty in Iskan­dar Put­eri, lo­cat­ed near Sin­ga­pore, be­tween Ju­ly 10 and Ju­ly 20. The site man­u­fac­tures ster­ile drugs, in­clud­ing in­sulin glargine, a biosim­i­lar ver­sion of Sanofi’s Lan­tus.

The 10-page re­port cites clean­ing de­fi­cien­cies for tools and prob­lems re­lat­ed to air­flow in asep­tic ar­eas. It al­so re­port­ed a lack of in­tegri­ty test­ing, which is done to en­sure there are no de­fects, such as tears or pin­holes, be­fore the man­u­fac­tur­ing of ster­ile drug prod­ucts.

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