Navigation Links
Guide for US FDA-Regulated Organizations Now Available
Date:4/29/2010

“How to Avoid and Respond to Public FDA Criticisms—Form 483 Letters—for Temperature, Humidity and other Controlled Environments”

(Vocus) April 29, 2010 -- “How to Avoid and Respond to Public FDA Criticisms—Form 483 Letters—for Temperature, Humidity and other Controlled Environments” is now available from Veriteq (www.veriteq.com), a Vaisala company, a leader in FDA-compliant environmental monitoring, alarming, reporting and temperature/humidity technology. The 10-step Guide is designed to help the wide range of pharmaceutical processors, blood and tissue banks, clinical laboratories, medical device manufacturers, research hospitals, and other GxP facilities who may receive public criticism warning letters respond quickly and appropriately within the permitted 15-day window. Proper FDA 483 letter response is critical to both help in reputation repair and for real remediation actions to assure a quality process and patient safety.

FDA 483 letters are expected to increase this year, reflecting the FDA’s recent staff expansion and rewrite of the FDA 483 Letter rules to narrow response time to the new 15-day window.

Ken Appel, Veriteq Manager Regulated Markets, comments, "Veriteq is keenly aware of the great number of FDA-regulated companies that thought they were in full compliance but were not when it came to temperature monitoring. Since Veriteq offers the only monitoring system that ensures both gap-free records and accuracy in between calibration intervals we have always had customers who came to Veriteq because they were using inferior solutions. Customers are often disappointed over the failure of chart recorders or data loggers to record data during facility power outages, hold calibration accuracy of sensors or other equipment failure that had triggered negative FDA actions or product loss. If and when a company receives a Warning Letter it is a matter of public record listed on the FDA's web site. Veriteq's guide-"How to Avoid and Respond to Public FDA Criticisms-Form 483 Letters-for Temperature, Humidity and other Controlled Environments" will help quality departments that have received such public criticism regroup, but more importantly, will give some best-practice tips that will help FDA-regulated organizations avoid Warning Letters in the first place."

To obtain a copy of the Guide fill out the request form at http://www.veriteq.com/fda_response.htm or contact: Janice Bennett, Veriteq Marketing Manager, 800-683-8374 (or +1-604-273-6850 outside North America), FAX 604-273-2874.

About Veriteq

Veriteq Instruments (www.veriteq.com), a Vaisala company, provides environmental monitoring of temperature, humidity and other critical variables in controlled environments for regulated industries and other critical storage applications where product loss or audit failures are unacceptable. A network of independent data recorders equipped with industry-best 10-year batteries deliver monitoring, alarming and reporting with a continuous record of data, immune from power outages and network interruptions. Headquartered in Richmond, BC, with a worldwide distributor network Veriteq serves thousands of users, from Global 500 companies and major learning, standards and government institutions to mid-sized research and manufacturing organizations.

About Vaisala
Vaisala is a global leader in environmental and industrial measurement. Building on more than 70 years of experience, Vaisala contributes to a better quality of life by providing a comprehensive range of innovative observation and measurement products and services for meteorology, weather critical operations and controlled environments. Headquartered in Finland, Vaisala employs over 1400 professionals worldwide and is listed on the NASDAQ OMX Helsinki. www.vaisala.com For more information: Pirjo Kortteisto, Director, Cleanrooms & Chambers, tel. +358 40 7683 826, or Liisa Ahtiluoto, Communications Manager, tel. +358 40 730 7695

Please address editorial inquiries to Amy Munice, ALM Communications, alm(at)almcommunications(dot)com, +1-773-862-6800, (skype) ALMCommunications.

# # #

Read the full story at http://www.prweb.com/releases/Veriteq/FDA_483/prweb3937084.htm.


'/>"/>
Source: PRWeb
Copyright©2010 Vocus, Inc.
All rights reserved  

Related medicine news :

1. Enjoy Pregnancy Without Foot Pain: Foot and Ankle Surgeon Offers Guidelines
2. Expert Approved: FatWallet Guides Mother's Day Shoppers to the Best Deals Online
3. Review Panel Leaves Controversial Lyme Disease Guidelines Unchanged
4. Physical Activity Guidelines for Americans interpreted for practical use
5. New Guidelines Issued on Hormone Receptor Testing for Breast Cancer
6. EAU launches new and updated clinical guidelines for 2010
7. Community research guidelines set stage for real world scholarship
8. 'What Women Really Want In Bed' Is A Man's Guide To Giving Her The Sex She Wants
9. Docs Issue Guidelines for Drivers With Dementia
10. The CPM Resource Center launches Web-based clinical practice guidelines
11. Guided Meditation Made Available to Everyone for Stress Awareness Month
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Guide for US FDA-Regulated Organizations Now Available
(Date:6/25/2016)... , ... June 25, 2016 , ... As a lifelong ... Cum Laude and his M.D from the David Geffen School of Medicine at UCLA. ... to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits ... terms of the latter, setting the bar too high can result in disappointment, perhaps ... slow progress toward their goal. , Research from PsychTests.com reveals that ...
(Date:6/24/2016)... ... 24, 2016 , ... June 19, 2016 is World Sickle Cell Observance Day. ... the benefits of holistic treatments, Serenity Recovery Center of Marne, Michigan, has ... , Sickle Cell Disease (SCD) is a disorder of the red blood cells, which ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Global law firm ... 2016 Legal Elite. The attorneys chosen by their peers for this recognition are considered ... Seven Greenberg Traurig Shareholders received special honors as members of this year’s Legal Elite ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway ... call for a minimum wage raise to $12 an hour by 2020 and then adjusting ... restore the lost value of the minimum wage, assure the wage floor does not erode ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 23, 2016 Capricor Therapeutics, ... a biotechnology company focused on the discovery, development ... patient enrollment in its ongoing randomized HOPE-Duchenne clinical ... 50% of its 24-patient target. Capricor expects the ... quarter of 2016, and to report top line ...
(Date:6/23/2016)... PARK RIDGE, Ill. and INDIANAPOLIS ... caliber of students receiving a Lilly Diabetes Tomorrow,s Leaders ... hands. The 2016 scholarship winners, announced today online at ... refused to let type 1 diabetes stand in the ... Lilly Diabetes has supported the Foundation,s scholarship program since ...
(Date:6/23/2016)... -- The vast majority of dialysis patients currently receive ... usually 3 times a week, with treatment times averaging ... equipment preparation and wait time.  This regimen can be ... who are elderly and frail.  Many elderly dialysis patients ... for some duration of time. Residents in ...
Breaking Medicine Technology: