U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Macular Health - Close Out Letter 10/28/16
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Macular Health 28/10/2016

Macular Health - Close Out Letter 10/28/16


Macular Health

 

  

Black HHS-Blue FDA Logo

 

 

 
New Orleans District
404 BNA Drive
Building 200- Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802 

October 28, 2016

Jeffery McAnnally, President
Lunovus, LLC (Formerly known as Macular Health)
8289 Highway 31 North
Morris, Alabama 3 5116

Dear Mr. McAnnally:

The Food and Drug Administration (FDA) completed an evaluation of your firm's corrective actions in response to our Warning Letter No. 2016-NOL-04, issued on April 28, 2016. Based on our evaluation, it appears you have addressed the violations contained in this warning letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
 

Sincerely,

/S/
Kimberly L. McMillan
Acting Compliance Branch Director
New Orleans District