Symmetry Medical, a maker of sterilization containers, failed to conduct audits of its quality system, a recent warning letter says.
The Nashville, Tenn., facility should have conducted quality audits at planned intervals, according to its quality manual, the letter says. However, no quality audits were conducted.
Additionally, the manual references a procedure that does not exist.
The company’s post-inspection response to this issue did not provide evidence that Symmetry implemented its proposed correction, including training, according to the Oct. 7 letter posted last month to the FDA website.
A June inspection found the facility did not establish procedures referenced in one of the company’s corrective and preventive action (CAPA) procedures.
Some of these procedures are required to identify sources of quality data to determine the need for a CAPA, the letter says.
Although the company’s post-inspection response included a copy of the revised CAPA procedure, training had not been completed, the letter adds.
The FDA also cites the company for training violations, stating that one employee reportedly received on-the-job training on inspection procedures for the sterilization containers but the training was not documented.
Symmetry further failed to develop, maintain and implement written medical device reporting procedures, the letter says.
The company responded to the warning letter Oct. 16 and has received notice from the FDA stating that the response and written procedures appear to address its concerns, D. Darin Martin, Symmetry’s senior vice president of quality assurance and regulatory affairs, told FDAnews.
“No further corrective actions are required,” Martin added.
The warning letter is available at www.fdanews.com/ext/files/ucm194367.pdf. — April Hollis
Copyright ©2018. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing