CHENGDU,March.1 (NBD)-- Chongqing Pharma Research Institute received a warning letter from FDA, claiming that it failed to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.
FDA says its quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness and quality of the drugs it manufacture. FDA also recommended it to retain a qualified consultant to assist its remediation.
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Editor:
Tan Yuhan