# FDA 483 - Global Calcium Pvt. Limited - February 22, 2019

Source: https://www.keypedia.com/records/483/global-calcium-pvt-limited/3fb2d05a-3aaf-441a-8f9a-75a95530e512

> 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: Division of Northeast Imports 
- Summary: The FDA inspected Global Calcium Pvt. Limited in Hosur, India, an API manufacturer, and issued a Form 483. The inspection revealed significant deficiencies in the firm's product quality complaint investigation process, including the failure to consistently request and test return product samples. Additionally, the firm demonstrated inadequate control over loose GMP documents, issues with equipment cleaning verification, and a lack of adequate training for employees handling product quality complaints.

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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/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94