The QMN Weekly Bulletin

Key Issues Can Make or Break Issuance of a Warning Letter

Feb. 24, 2012

A Florida surgical lamp company recently received a warning letter citing a variety of GMP violations.

Light-Tech did not have adequate design control procedures and did not identify, verify, review or approve design changes before implementation, especially in the case of a switch from halogen bulbs to LED illuminators, according to the letter.

Weak SOPs are cropping up again and again in recent warning letter citations, and the agency is seeing other trends as well, including increasing problems with clinical trial sites.

In December 2011, a principal investigator who confessed to disregarding her trial responsibilities received an FDA warning for “systemic failures” in trial conduct that include failing to personally execute or adequately oversee two trials, as well as protocol deviations.

And these findings are the tip of the iceberg. Don’t be caught without key knowledge on warning letter trends for GMP inspections, clinical trials and product marketing.

One warning letter — one disciplinary action that puts you in a bad light with the FDA and your customers — is one too many! Why risk it when FDAnews does the hard work for you: FDA Drug Enforcement: An Analysis of Warning Letter Trends.

This report is a must read for drug and biologics makers, clinical trial sponsors, government regulators and everyone whose livelihood is affected by FDA inspections.

Don’t wait until the FDA is on your back, order this handy guide today!