Company: Baxter (Claris Injectables Ltd.) Date: 7/5/18 Data Integrity Remediation: Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. In response to this letter provide the following. A. A comprehensive investigation into the extent of the inaccuracies in data,...Read More

Baxter (Claris Injectables Ltd.) Product: drug manufacturing facility Date:7/5/18 Data Integrity Remediation Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. In response to this letter provide the following. A. A comprehensive investigation into the extent of the inaccuracies...Read More