FDA Warns Symmetry Medical for Audit, CAPA Violations

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.
The GMP Letter