USFDA concludes GMP inspection at Madhya Pradesh manufacturing facility of MEDI-CAPS’s arm

24 Feb 2025 Evaluate

United States Food & Drug Administration (USFDA) has concluded GMP inspection at MEDI-CAPS’s Wholly Owned Subsidiary Company - Medgel’s Madhya Pradesh manufacturing facility. The inspection was conducted from February 17, 2025 to February 21, 2025. At the conclusion of the inspection on February 21, 2025, form 483 was issued to the company.

There were no observations related to data integrity, and all the observations were procedural in nature. The company will work in close collaboration with the agency to address the observations and will respond to the USFDA within stipulated timeline.

Medi-Caps incorporated in 1986  is a flagship company of Medi-Caps Group, is one of the largest manufacturer of empty hard gelatin capsules in terms of manufacturing capacity as well as market capitalization in India. 

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