Warning letters, 483s, Recalls, Import Alerts, Audit observations
Indian API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in
FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing
Accord Healthcare Inc, US is recalling one lot of Cisplatin injection due to failed impurities.
Dr.Reddy’s laboratories Inc (DRL) has initiated recall of 50 batches of Ibuprofen tablets in US
Chinese API Manufacturer Sichuan Deebio Pharmaceuticals was awarded USFDA 483 with six observations citing Data
Glenmark Pharmaceuticals Inc., USA is recalling one lot of Esomeprazole Magnesium Delayed-Release Capsules. The recall
