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Pharmaceuticals / Inspections and Audits

FDA Hits Izeen Pharma With Lengthy 483

Nov. 13, 2018

Contract drugmaker Izeen Pharma of Frederick, Maryland, drew a 21-page Form 483 from the FDA for numerous deficiencies, including inadequate validations and poor data handling.

During an inspection between June 4 and July 7, the agency questioned the security and accuracy of the quality control laboratory’s electronic data.

For example, the facility didn’t retain raw data from tests performed on different dosages of its thyroid tablets. When reprocessed samples were saved, the original data file was overwritten, resulting in only the last modified file being kept, the investigator found. Additionally, the original data could be deleted from the computer where the data files are stored.

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