> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Global Calcium CGMP Deviations
- URL: https://www.fdaweb.com/global-calcium-cgmp-deviations/
- Published: 2025-02-04T12:00:00.000Z
- Updated: 2026-09-14T14:52:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158596

A 7/29-8/2/2024 FDA inspection at the Global Calcium drug manufacturing facility in Tamil Nadu, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 1/16 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-calcium-pvt-limited-692000-01162025?ref=fdaweb.com) says the specific deviations were:

- failure of the firm’s quality unit to prepare, review, and approve documents related to the manufacturing of APIs following written procedures;
- failure to properly maintain buildings and facilities used in the manufacture of APIs; and
- failure to establish an impurity profile for identified and unidentified impurities.

FDA recommends the firm engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. It notes it placed a 12/20/2024 Import Alert on the firm’s products.

Global Calcium was told to correct deviations promptly and to respond with a list of specific actions it has taken to address the deviations and prevent their recurrence, with a schedule for completing the corrections.