483
Global Calcium Pvt. LimitedGlobal Calcium Pvt. Limited – FDA 483, Apr 6, 2015
Record Details
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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ID · 60e2a478-ae2f-469d-a0fa-9ad13cc41216
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