FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Taiwanese API Manufacturer Hit for Sanitization Issues

Oct. 10, 2018
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The FDA cited New Taipei City manufacturer Delta Synthetic for its methods of sanitizing the facility’s water system.

During a July 2-6 inspection of the API manufacturing facility, an agency investigator noted that the firm did not conduct adequate routine maintenance and cleaning and sanitization of the water system.

The inspector found the company had numerous out-of-specification and out-of-trend results. Multiple times, the firm’s quality unit neglected to conduct an investigation to determine the root causes of OOS and OOT results.

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