U.S. FDA issues two observations for Gland Pharma facility
Gland Pharma’s facility in Dundigal, near Hyderabad, has been issued a Form 483 with two observations on conclusion of a surprise inspection by the United States Food and Drug Administration (U.S. FDA). These are procedural in nature and neither repeat observations nor related to data integrity, the company said. The corrective and preventive actions will be submitted to the U.S. FDA within the stipulated period. The inspection of the facility for Good Manufacturing Practices was conducted between July 22 and July 25, the generic injectable-focused company said in a filing on Thursday.
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