As posted in the Eudra GMDP database, the Italian Medicines Agency found Sri Krishna Pharma’s Hyderabad, India plant to be in non-compliance with GMPs in mid-December, following an inspection earlier in the month. The facility was cited for: ● lot rejection and using “trial” samples ● lab controls ● missing or poor quality agreement, and ● torn and discarded batch records. In late December, the French National Agency for Medicines and Health Products Safety found Medreich Limited’s Andra Pradesh, India plant to be in non-compliance after an inspection in early 2013. The plant was cited for: ● data falsification ● quality management ● personnel qualification ● equipment maintenance ● documentation, and ● production issues.
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