URGENT NEWS FOR ALL CLIENTS

If you are submitting samples in response to an FDA request or automatic detention notice, you must immediately contact our laboratory and advise us of this matter.   There are very specific requirements for private laboratory data submissions to the FDA as outlined in ORA Section 7 that must be satisfied.   Do not waste your time and money having testing conducted only to have it rejected by a Compliance Officer.   When contacting us, please provide the following information:

1. Exact description of the material being detained and why
2. Nature of the detention and if you have a conditional release on the material
3. Let us know if   the FDA is allowing you to sample or   if they require a 3rd party to sample
4. Advise us if   you want our laboratory to sample the material or a 3rd party
5. Provide the name and contact information for the Compliance Officer handling your detention
6. Provide signed written authorization on your company letterhead for us to contact the Compliance Officer
7. Let us know if this is the first time you have had a detained shipment or if this is in response to a prior recall issue with your company/product
8. Details or facts that may be important regarding your unique situation

The requirements to satisfy ORA 7 are much more time consuming and demanding than   routine analysis requirements and each FDA Compliance Officer might have special concerns or areas of focus.   In order to help you meet your needs, we have developed this guidance page.   For the most updated requirements, contact the FDA directly. This page may not contain the most current ORA issues.