FDAnews
www.fdanews.com/articles/131467-fda-warns-frontier-medical-for-not-following-procedures

FDA Warns Frontier Medical for Not Following Procedures

October 29, 2010
Nonexistent forms and procedure failures resulted in a warning letter to Frontier Medical Products, which makes blood pressure cuffs.

The company also has not submitted its annual establishment registration or device listings since 2007, according to the letter that stems from a June inspection of Frontier’s Port Washington, Wis., facility.

Frontier promised to correct all the issues cited. The response is inadequate, the FDA says, because it does not include documentation showing how the violations will be corrected.
The GMP Letter