Shilpa Medicare Hyderabad Unit Gets 1 Procedural Observation in USFDA Inspection
Hyderabad: Shilpa Medicare Limited has received one procedural observation from the United States Food and Drug Administration (USFDA) following a surveillance inspection at its Analytical Services Division in Hyderabad from September 16 to September 18, 2026.
The inspection was carried out at Unit VII of the company’s Analytical Services Division, located at Plot No. 79, Road No. 15, Survey No. 125, IDA Mallapur, Nacharam, Uppal Mandal, Medchal, Malkajgiri District, Hyderabad, Telangana.
According to the company’s regulatory disclosure, the observation issued at the conclusion of the inspection was procedural in nature and was neither a repeat observation nor related to data integrity.
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Shilpa Medicare said it will submit a comprehensive response to the USFDA within the stipulated timeline and address the observation through appropriate corrective and preventive actions (CAPA).
The company said it does not expect the development to have any material impact on its current business operations or existing supplies from the facility.
Shilpa Medicare Limited is a pharmaceutical company headquartered in Raichur, Karnataka, with its corporate and administrative office at Shilpa House, Hyderabad Road, Raichur.
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