FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Chinese OTC Maker Nailed for Data Integrity

Nov. 14, 2019
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Data integrity and quality violations netted OTC drugmaker AMO Hangzhou a Form 483 following an FDA inspection of its facility in Hangzhou, Zhejiang.

The agency’s investigators took issue with the company’s computer controls. For example, the facility lacked audit trails for filter integrity tests prior to Dec. 2018 because it failed to back up system audits for test instruments, and deleted electronic data could not be retrieved.

Employees shared administrator functions or non-unique passwords, enabling others to delete test data, and one operator of the filter integrity test instruments had a password that didn’t meet requirements, the Form 483 said.

Responsibilities and procedures for the quality control unit weren’t fully followed or described in writing, the investigator found.

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