India Hits Wockhardt with Notices for Insects, BioMedical Waste, Rodent Excreta
India's State Food and Drug Administration officials issued "show cause" notices to Wockhardt Limited’s three pharma plants in Waluj and Chikalthana villages in Maharashtra and sought explanation about poor GMP compliance, according to India newsource dna.
Last December, Maharashtra FDA instituted a three-member special investigation team (SIT), which made appalling discoveries in the three plants. Some of the discoveries, according to dna, include "biomedical waste dumped openly, rusted drums containing glycerine," "proliferation of insects, rodent excreta which raises a stink and storage of raw material in rusted barrels," and "used gloves and medicine packs lying in the open yard."
State commissioner Mahesh Zagade confirmed that the notices were issued and that Wockhardt has a week to respond. Failure to step up compliance efforts could result in a suspension or cancellation of manufacturing licences.