Cadila Healthcare Ankleshwar facility successfully completes USFDA inspection

Written by Medical Dialogues Bureau Published On 2019-08-01T09:25:35+05:30 | Updated On 16 Aug 2021 2:59 PM IST

"The United States Food and Drug Administration (USFDA) inspected the company's active pharmaceutical ingredient manufacturing facility located at Ankleshwar from July 22 to July 26, 2019," Cadila Healthcare added.

New Delhi: Drug firm Cadila Healthcare recently said it has received no observations from the US health regulator for the inspection of its manufacturing plant at Ankleshwar in Gujarat.

"Drug firm Cadila Healthcare on July 26 said its manufacturing plant at Ankleshwar in Gujarat has completed inspection by the US health regulator with no observations," the company said in a filing.

This audit covered both Units I and II. At the end of the inspection, no 483 observations were issued, it added.

The USFDA Form 483 is officially called a "Notice of Inspectional Observations," commonly referred to simply as a "483." The 483 is issued at the end of an on-site inspection if the FDA field investigator observed deficiencies in the quality system or conditions that violate the Food, Drug, or Cosmetic Act.

Medical Dialogues had earlier reported that Cadila Healthcare had received Establishment Inspection Report from USFDA with voluntary action indicated (VAI) classification for its Ahmedabad SEZ facility.

The company is headquartered at Ahmedabad in Gujarat state of western India. It is a manufacturer of generic drugs and was founded in 1952 by Ramanbhai Patel (1925–2001), formerly a lecturer in the L.M. College of Pharmacy, and his business partner Indravadan Modi.

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Source : with inputs

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