# Global Calcium Pvt. Limited – FDA 483, Feb 22, 2019

Source: https://www.keypedia.com/records/483/global-calcium-pvt-limited/0a0bb32c-593a-4a85-83e6-d4bdc7524076

> FDA 483 for Global Calcium Pvt. Limited on February 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Global Calcium Pvt. Limited
- Inspection Date: 2019-02-22
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: An FDA inspection of Global Calcium Pvt. Limited, an API manufacturer in Hosur, India, revealed significant deficiencies across multiple areas. The firm's processes for investigating product quality complaints were inadequate, and there were issues with good documentation practices for GMP documents. Additionally, the clean status of equipment could not be verified, and employees responsible for complaint handling lacked adequate training.

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Company: https://www.keypedia.com/companies/global-calcium-pvt-limited/274540f7-e7a4-47fb-b3a0-61fb5e85d807

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c