FDA Warns Taiwanese Firm Over GMP Violations
The US Food and Drug Administration (FDA) last week warned Taiwanese firm Pacific Hospital Supply Co for failing to meet good manufacturing practice (GMP) standards.
The warning letter comes roughly a year after FDA inspected the company's Miaoli, Taiwan facility where it manufactures disposable medical devices including catheters, cannulae, tubing and aspirators.
Among the violations cited in the letter, FDA said Pacific Hospital Supply failed to validate some of the processes used to manufacture its products, a repeat observation from a previous inspection.
FDA also said the company failed to establish and maintain process control procedures that ensure conformance to predetermined specifications.
For instance, FDA said its investigator found some equipment running at a different operating temperature and speed than in the company's written procedures, another repeat observation.
And FDA said the company failed to establish and maintain procedures for implementing a corrective and preventative action (CAPA).
In one CAPA initiated in October 2010 that was initiated due to failed tests for one of its products, Pacific Hospital Supply closed out the CAPA after determining that a process change and component redesign would address the issue.
However, FDA said that at the time of the inspection, the component redesign was still not complete, and the company had not revalidated the process change until months after it had closed the CAPA.
As a result of the issues cited in the warning letter, FDA said it will not approve any premarket approval applications submitted by Pacific Hospital Supply until the issues are corrected.