The QMN Weekly Bulletin
Medical Devices / Inspections and Audits

Pacific Hospital Supply Warned for Validation, Process Control Issues

March 2, 2018

The FDA hit Pacific Hospital Supply, a manufacturer of disposable medical supplies including catheters, cannulae, tubing, and aspirators, with a warning letter after an inspection at the firm’s Miaoli, Taiwan facility revealed adulterated products.

During a February 2017 inspection, the agency found that the firm failed to ensure that when the results of a process could not be fully verified by subsequent inspection and test that the process was validated. One of the manufacturing processes the firm failed to validate was also flagged in a previous FDA inspection.

The facility failed to follow adequate process control procedures. For example, equipment in the facility was operating at temperature and speed settings that were outside defined limits. In addition, the firm had not resolved a Form 483 observation from its last inspection, failing to establish a required procedure.

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