483
Global Calcium Pvt. LimitedGlobal Calcium Pvt. Limited – FDA 483, Feb 22, 2019
Record Details
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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ID · 0a0bb32c-593a-4a85-83e6-d4bdc7524076
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