www.fdanews.com/articles/123831-fda-warns-symmetry-medical-for-audit-capa-violations
FDA Warns Symmetry Medical for Audit, CAPA Violations
January 20, 2010
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, but, no quality
audits were conducted. Additionally, the manual references a procedure that does not exist.
The GMP Letter
The GMP Letter