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FDA Calls Out Korean Manufacturer Over Contamination Concerns

August 14, 2018

An FDA inspection of Korean sterile OTC drug manufacturer Hanlim Pharm in January turned up multiple failures to follow procedures for preventing product contamination.

The investigator noted numerous violations in filling operations. For example, operators reached over open, empty bottles used in the filling line for up to a minute at a time, risking contamination, and stopped the line multiple times to address issues such as bottle jams without documenting them in the batch records.

“On several occasions after removing jams the operator leaned their torso and head inside the restricted access barrier system to clean the equipment with a clean room cloth,” according to the Form 483 report. Operators failed to make slow and deliberate movements within the Grade A area during filling activities, including while loading supplies and removing bottles from the jammed belt.

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