Free Download:
“How to Respond to (and Avoid) FDA Form 483s for Temperature, Humidity and other Controlled Environments”

February 12, 2010

Vancouver, British Columbia, Canada

“How to Respond to (and Avoid) FDA Form 483s for Temperature, Humidity and other Controlled Environments” is now available from Veriteq Instruments, the industry leader in FDA-compliant environmental monitoring, alarming, and reporting. To obtain a copy of the guide, please visit Veriteq's FDA 483 Article Download page.

This new 10-step guide explains how to create a proper response to the FDA’s Form 483. Aimed at pharmaceutical manufacturers and processors, clinical laboratories, medical device manufacturers, blood and tissue banks and other GxP facilities, the guide outlines the characteristics of an appropriate response and offers several references for further research.

An adequate FDA 483 letter response is not only critical to staying in good standing with the agency, it can help quality professionals formulate a feasible plan of action to ensure optimal quality processes, product efficacy and patient safety.

FDA 483 letters are expected to increase this year, reflecting the FDA’s recent staff expansion and shortened 483 response time limit to 15 days from the date of receipt. All 483 observations are a matter of public record because each issuance is listed on the FDA's Office of Regulatory Affairs Electronic Reading Room (ORA FOIA) under "Inspections, Compliance, Enforcement, and Criminal Investigations.” Regulated facilities are therefore encouraged to adhere to cGMP and respond quickly when they are listed as possibly non-compliant.

Ken Appel, Veriteq Vice President Regulated Markets, says "We’ve witnessed several FDA-regulated companies that thought they were in full compliance but were not when it came to environmental monitoring and documentation. Since Veriteq offers the only monitoring system that ensures both gap-free records and sensor accuracy in between calibration intervals, we have numerous customers who chose our system because inferior solutions had resulted in Form 483 observations.”

Appel notes that most new Veriteq customers sought a better solution after having suffered compliance deviations due to the failure of chart recorders or data loggers that were unable to record data during facility power outages or network downtime. “Other temperature and humidity sensors are not as stable as Veriteq’s,” says Appel. “Inaccurate or missing data can not only trigger a 483 following an FDA inspection, it can reveal serious flaws in a facility’s quality system.”

Veriteq's new publication “How to Respond to (and Avoid) FDA 483s” gives quality and compliance professionals a ten steps of best practices for dealing with post-inspection observations of possible deviations from cGMP.

To obtain a copy of this 10-step guide, please fill out the request form at http://www.veriteq.com/fda_response.htm or call 800-683-8374 (or +1-604-273-6850 outside North America).

About Veriteq Instruments

Veriteq provides fail-safe records for temperature, humidity and other variables in controlled environments where serious financial or regulatory consequences are at stake. An easily scalable network of independent recorders with best-in-class accuracy, Veriteq’s monitoring, alarming and reporting solutions are ideal for applications subject to audit.

For further information call 800-683-8374 (North America only) or 604-273-6850.