# Global Calcium Pvt. Limited – FDA 483, Apr 6, 2015

Source: https://www.keypedia.com/records/483/global-calcium-pvt-limited/60e2a478-ae2f-469d-a0fa-9ad13cc41216

> FDA 483 for Global Calcium Pvt. Limited on April 06, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Global Calcium Pvt. Limited
- Inspection Date: 2015-04-06
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Global Calcium Private Limited, a drug API manufacturer in Hosur, India, revealed significant deficiencies in laboratory controls and data integrity. The inspection found issues including inadequate controls over computerized systems, unvalidated analytical methods, uncalibrated equipment, and failures to follow SOPs. Additionally, the firm lacked complete records for sample handling, proper storage of reagents and standards, and verifiable process validation data.

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## Related Officers

- [Investigator ](https://www.keypedia.com/people/larry-k-austin/174b94ad-67d6-4610-8a32-eb5cffbfc37d)
- [Luis M. Burgos Medero](https://www.keypedia.com/people/luis-m-burgos-medero/cb24a030-6593-44cf-be60-cebb2f1104b4)

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4