 "Drugs, Pharma, medicine")
India’s leading drug maker Sun Pharmaceutical Industries has received four observations for its Halol facility in Gujarat following an inspection by the US Food and Drug Administration (USFDA).
The USFDA has flagged that the facility is not following procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile.
The regulator has also observed that lab control mechanisms were not documented, design plans not adequately established, and the processes whose results could not be fully verified by subsequent inspection were not adequately validated.
Sun Pharma has said it will respond to the observations soon. “Sun Pharma
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