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Sun Pharma’s Halol plant is in trouble yet again. This time it has received six adverse observations in a US Food and Drug Administration (FDA) inspection, two months after the regulator lifted its previous warning.
Halol, a key plant for the drug maker to manufacture injectables and specialty drugs, was under regulatory scanner since 2014. The plant got a clearance in July.
An inspection was carried out by the US drug regulator in the Halol plant in August, during which it detected a few lapses, including inadequate laboratory facilities, absence of required procedures to prevent objectionable microorganisms in drugs,
