FDA 483 - TAIWAN BIOTECH CO., LTD. - September 11, 2017

During an inspection conducted from September 1-11, 2017, the FDA issued a Form 483 to TAIWAN BIOTECH CO., LTD., a manufacturer of sterile drug products. The inspection revealed critical deficiencies across the company's laboratory control and quality systems.

Key issues included an inadequate environmental monitoring program for aseptic processing areas. Inspectors discovered numerous unread environmental monitoring plates, indicating a failure to investigate out-of-specification results over a significant period. Furthermore, personnel and surface monitoring were inconsistent, and essential growth promotion testing for environmental monitoring media was not performed. Records for these samples were incomplete.

Additional observations noted that the company failed to consistently follow its written stability testing program, resulting in delayed testing and a lack of investigations into these delays. Documentation for stability samples was also found to be incomplete. The quality system demonstrated weaknesses with an inadequate electronic system for tracking deviation investigations, exhibiting skipped and duplicated control numbers. Finally, annual product reviews were found to be deficient, as they did not include comprehensive data necessary to fully evaluate drug product quality. TAIWAN BIOTECH CO., LTD. is responsible for implementing prompt corrective and preventive actions to address all identified violations.