Date:
April 23, 2026
Content:
The U.S. Food and Drug Administration (FDA) has published a Form 483 regarding an inspection of Global Calcium Private Limited, a pharmaceutical manufacturer located in India.
The report outlines specific inspectional observations identified by FDA investigators during their visit to the facility in early 2026. Form 483s are issued when investigators observe conditions that may constitute violations of the Food, Drug, and Cosmetic Act or related manufacturing regulations.
These observations serve as a formal notification for the company to review and address potential gaps in their quality control or production processes. Global Calcium Private Limited is expected to submit a corrective action plan to the FDA to demonstrate how they will resolve the identified issues and ensure compliance with Current Good Manufacturing Practice (cGMP) standards.
Source: FDA Electronic Reading Room
Link:
http://www.fda.gov/drugs/cder-foia-electronic-reading-room/global-calcium-private-limited-02032026
Keywords:
FDA, Global Calcium Private Limited, Form 483, India, Drug Manufacturing, cGMP Compliance, Inspectional Observations