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California Manufacturer Earns 4-Item 483 Over Poor Lab Controls

June 23, 2016

The FDA served a California drugmaker with a four-observation Form 483 after an inspection revealed inadequate laboratory controls.

An inspection in January found that Biozone Laboratories relied on laboratory control mechanisms that had not been approved by its quality control unit.

The agency also called into question the reliability of the company’s electronic records, with an inspector noting that they that failed to meet agency requirements for validation, access restrictions and audit trails. In particular, the company’s software lacked an audit feature to document activities such as the alteration or deletion of data.

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