Gland Pharma gets 2 USFDA observations for Dundigal facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-07-25 09:58 GMT | Update On 2024-07-25 09:58 GMT
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Telangana: Gland Pharma has announced that the United States Food and Drug Administration (US FDA) has concluded a surprise inspection of the Company's Dundigal Facility at Hyderabad for Good Manufacturing Practices (GMP) with two 483 Observations.
The inspection was conducted between 22nd July, 2024 and 25th July, 2024
"These observations are procedural in nature. The corrective and preventive actions for these observations will be submitted to the US FDA within the stipulated period. The observations issued are neither repeated observations nor related to data integrity," Gland Pharma stated.
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