Indian pharma receives FDA warning letter for barefoot employees and general ‘disrepair’

Fol­low­ing a ma­jor re­call of eye drop prod­ucts, In­dia-based phar­ma Kil­itch Health­care re­ceived a warn­ing let­ter from the FDA not­ing that mul­ti­ple em­ploy­ees were work­ing bare­foot in des­ig­nat­ed clean rooms, and in some cas­es, sam­ple re­sults were fab­ri­cat­ed.

The warn­ing let­ter, pub­lished on Tues­day and sent to Kil­itch on March 28, fol­lows an Oc­to­ber 2023 in­spec­tion at Kil­itch’s fa­cil­i­ty in Mum­bai.

The fa­cil­i­ty was in a state of “dis­re­pair,” ac­cord­ing to the warn­ing let­ter, with the FDA in­spec­tors not­ing peel­ing paint, stains and residues.

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