FDA re­veals clean­ing and test­ing is­sues at Glob­al Phar­ma In­di­an man­u­fac­tur­ing site

Glob­al Phar­ma Health­care’s man­u­fac­tur­ing site in In­dia has been in­spect­ed by the FDA, re­veal­ing sev­er­al stark qual­i­ty is­sues.

The 14-page re­port gave de­tails of an FDA in­spec­tion made at Glob­al Phar­ma’s on­ly man­u­fac­tur­ing site in the town of Thiru­porur, just to the south of the city of Chen­nai.

Back in Feb­ru­ary, Glob­al Phar­ma vol­un­tar­i­ly re­called all lots of its Ar­ti­fi­cial Tears Eye Drops af­ter the CDC alert­ed the FDA to an in­ves­ti­ga­tion of a clus­ter of en­zymes that can pro­duce in­fec­tions. The FDA’s re­call re­port in Feb­ru­ary states that there were 55 re­ports of ad­verse events from pa­tients us­ing the drops, in­clud­ing eye in­fec­tions, per­ma­nent loss of vi­sion, and one death.

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