Your GAWDA Medical Gas Consultants have helped over 250 locations assure compliance with the FDA's new electronic registration requirements. We have had face-to-face meetings with the FDA to help streamline the process. The FDA still has some problems with their Dun and Bradstreet interface, but most of the serious problems with the registration process are corrected.
We can complete your FDA electronic registration for you with a minimum of cost and effort on your part. Or, if you prefer, we can provide the SOPs and recorded training which guide you through the process. If you would like more information about the latest SOPs or online tech support for FDA registration/listing, send a message to email@example.com.
If you want to have us do your registration for 2010, here is the information we need to get started:
- Company Corporate Name:
- Company Corporate Address:
- Company Corporate Contact:
- Company Corporate Contact phone number:
- Company Corporate Contact email:
- Company Corporate DUNS Number:
- Company Corporate Labeler Code(s):
- Production Site Name:
- Production Site Address:
- Production Site Contact:
- Production Site Contact phone number:
- Production Site Contact email :
- Production Site DUNS Number:
- Production Site Registration Number:
As mentioned in earlier messages, if you were registered in 2009, you generally have until the end of 2010 to re-register with the FDA. The major exceptions to this "calendar year" annual registration requirement are when a location is sold, changes names or is moved. We encourage you to complete the registration early, but in most cases, it will not impact compliance if you wait a few months.
January Medical Gas Roundtable
Medical Gas Roundtables are monthly compliance updates and documented training. These online events are easy ways to stay current on the latest developments in FDA compliance.
Due to a special meeting with the FDA in December, the Medical Gas Roundtable was postponed to January 8, 2010. We will cover the new GAWDA SOP training modules available and Subpart G, Packaging and Labeling Control.
If you are interested in attending this online meeting or if you need additional information, contact Tom Badstubner at 508-883-0927 or firstname.lastname@example.org.
This section of the Medical Gas Bulletin lists small steps you can take each month to improve your medical gas management system. These steps are not designed to be a full audit, but rather small steps to sample your compliance.
For January, simply do these items:
- Label Contents - Verify that your labels list the contents for the container in cubic feet, liters, pounds, gallons, etc.
- Rx Only - Assure your labels have the Rx Only legend. This is often missing on drug gases other than oxygen& for example on nitrogen, nitrous oxide, carbon dioxide, medical air, etc.
We have developed an easy to use checklist of the various requirements for medical gas labels (DOT, FDA, etc.) Let us know if you want a copy of the checklist.
GAWDA Medical Gas Consultant