PRTODAY / NewswireToday Free press release distribution service network

Written by / Agency / Source: LANXESS

Check Ads Availability|e-mail Article


Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!

Seal of Quality for LANXESS Subsidiary - Saltigo Passes FDA Audit - Saltigo GmbH has passed an audit by the U.S. Food and Drug Administration (FDA) with a “No Findings” rating
Seal of Quality for LANXESS Subsidiary - Saltigo Passes FDA Audit

 

NewswireToday - /newswire/ - Leverkusen, Germany, 2010/06/25 - Saltigo GmbH has passed an audit by the U.S. Food and Drug Administration (FDA) with a “No Findings” rating. FRA: DE Frankfurt: LXS

   
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Manufacturing/Robotics Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Saltigo’s Managing Director Wolfgang Schmitz is delighted that the official auditors did not have any objections: “The FDA audit is an internationally accredited seal of quality and recognizes all the work we have put in. This shows not just U.S. customers but also pharmaceutical companies throughout the world that with us the production of active ingredients is in safe and reliable hands.”

The audit focused on testing production and quality assurance processes for an active ingredient that a Saltigo customer is looking to supply in the United States in the near future. It involved the auditors inspecting Saltigo’s production and quality assurance systems in Leverkusen over five days. As part of this pre-approval inspection, the FDA assesses whether a medical product can be manufactured at the company’s production facilities using technology that is recognized in the United States as state-of-the-art and in compliance with applicable CGMP rules (Current Good Manufacturing Practice).

The auditors also inspect quality assurance systems and all the facilities used, from water treatment plants and cleanrooms to filling plants and process control technology. Immediately afterwards, the FDA announces the results of its audit, ranging from “No Findings” and “Form 483” (negative findings observed) to the “Warning Letter” (critical negative findings).

“An FDA audit is a particularly tough test,” says Dr. Carsten Hesse, responsible for quality assurance in the Pharma business line at Saltigo. “This excellent “No Findings” result is a testament to our high standards. But meeting CGMP requirements with ease and flexibility and doing so in all scales of synthesis is all in a day’s work for us.”

The Saltigo service portfolio ranges from synthesis design and process development and optimization to support for registration and approval.

Saltigo GmbH is a leading supplier in the field of custom synthesis. The company of specialty chemicals group LANXESS belongs to the Advanced Intermediates segment, which achieved total sales in 2009 of EUR 1,104 million. Saltigo, headquartered in Langenfeld and with production facilities in Leverkusen and Dormagen, employs around 1,400 staff worldwide. LANXESS Corporation (lanxess.com) operates a site for Saltigo in Redmond (Washington, United States).

 
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Manufacturing/Robotics Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Written by / Agency / Source: LANXESS

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick Newswire Today Visibility Checker

 

Distribution / Indexing: [+] / [Company listed above is a registered member of our network. Content made possible by PRZOOM / PRTODAY indexing services]

 
 
# # #
 
 
  Your Banner Ad showing on ALL
Manufacturing/Robotics articles,
CATCH Visitors via Your Competitors Announcements!


Seal of Quality for LANXESS Subsidiary - Saltigo Passes FDA Audit

Company website links NOT available to basic submissions
It is OK to republish and/or LINK any newswire for any legitimate media purpose as long as you name Newswire Today and LINK as the source.
 
  Is this your article?
Activate ALL web links and social stream by Upgrading to Press Release PREMIUM Plan Now!

LANXESS Press |
Publisher Contact: Ilona Bolz - LANXESS.com 
+49 214 30 61684 ilona.bolz[.]lanxess.com
 
Newswire Today - PRZOOM / PRTODAY disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any LANXESS securities in any jurisdiction including any other companies listed or named in this release.

Manufacturing/Robotics via RSSAdd NewswireToday - PRZOOM Headline News to FeedBurner
Find who RetweetFollow @NewswireTODAY



Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!


Read Latest Articles From LANXESS / Company Profile


Read Manufacturing/Robotics Most Recent Related Newswires:

BASF Launches Ucrete MF40AS Industrial Flooring System on the European Market
Raritan Unveils Intelligent Cabinet Concept in Collaboration with Legrand Data Communications At Gartner Conference
Beretta Continues Global Celebration of its 490th Anniversary with Unveiling of One-of-a-Kind Shotgun in New York City
LANXESS Virkon S Proven to Kill Highly Pathogenic Avian Influenza Strains
BASF to Offer Tailor-made Product Innovation At European Coatings Show
Nexans to Drive Sustainable Transportation At its Annual Technical Conference
Tripp Lite Introduces A New Series of Pre-assembled 40 Gb to 10 Gb Breakout Fiber Patch Panels
Borealis and Asmidal Sign Memorandum of Understanding to Jointly Evaluate Opportunities for Melamine Production in Algeria
SCHOTT’s New Ultra-Thin Glass is the Thinnest, Toughest, Most Eco-Friendly Glass for Consumer Electronics
Hexagon Manufacturing Intelligence Supplies PTB with Leitz PMM-G
Atlas Copco Completes Acquisition of Chinese Self-pierce Riveting Solutions Business
SCHOTT Introduces Superior X-ray Imaging with SCHOTT’s Fiber Optic Faceplates and BOROFLOAT® Glass
PPG Wins Big At 2016 SEMA Show PPG-painted Cars, Trucks Capture Major Awards
Tripp Lite’s Breakthrough 3-Phase Rack ATS PDUs Granted U.S. Patent
Nexans Launches PVC-free MOTIONLINE® HALEX Automation Cables

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
NewswireToday Celebrates 10 Years in Business


PREMIUM Members


Visit  JobsWare.com

Visit  Triggr & Bloom





 
  ©2016 Newswire Today — Limelon Advertising, Co.
Home | About | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR free press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneurs newswire distribution prtoday.com freenewswiredistribution asianewstoday bizwiretoday USA pr UK today - NOT affiliated with PRNewswire as we declined their partnership offer in 2013
 
PRTODAY & NewswireTODAY are NOT affiliated with USA TODAY (usatoday.com)