Aurobindo Pharma’s formulation manufacturing unit in Telangana’s Sangareddy district has been issued a Form 483 with one observation by the U.S. Food and Drug Administration.
The observation is procedural in nature and it will respond within the stipulated timelines, Aurobindo said on Saturday in a filing about the U.S. FDA inspection of Unit VI-B from September 22-29.
The U.S. FDA issues Form 483, on completion of inspection, notifying the company’s management of the objectionable conditions observed by its investigators that may constitute violations of the Food Drug and Cosmetic Act and related Acts. Earlier this month, it had issued a Form 483 with one observation to the formulation manufacturing facility of Aurobindo’s wholly owned subsidiary APL Healthcare in Naidupeta mandal of Tirupati district, Andhra Pradesh.
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