Granules India’s Gagillapur facility classified as “Official Action Indicated” following US FDA…
Company responds to observations and initiates improvements in collaboration with external experts
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Official Action Indicated
US FDA designates Cipla’s Goa plant as ‘Official Action Indicated’
The US FDA may continue to withhold product approvals from this facility till the outstanding observations are resolved
US FDA cautions Aurobindo Pharma’s oral solids formulation facility of regulatory action
According to US FDA's definitions, OAI means "objectionable conditions were found and regulatory administrative sanctions by FDA…
Torrent Pharma gets warning letter from US FDA for Gujarat facility
The company is committed in maintaining the highest standards of compliances and quality manufacturing across all its facilities…