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. A.I.G Technologies, Inc. - 490872 - 02/18/2020
  1. Warning Letters

CLOSEOUT LETTER

A.I.G Technologies, Inc. MARCS-CMS 490872 —

Delivery Method:
VIA UPS
Product:
Drugs

Recipient:
Recipient Name
Stephen Dawes
Recipient Title
Technical Director
A.I.G Technologies, Inc.

5001 NW 13th Avenue
Suite B
Deerfield Beach, FL 33064
United States

Issuing Office:
Office of Pharmaceutical Quality Operations Division II

United States


Mr. Dawes,

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [WL # 490872 dated December 5, 2017]. Based on our evaluation, it appears that 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.

If you have questions regarding the contents of this letter, you may contact Jamillah Selby via phone at 215-490-8417 or email at Jamillah.selby@fda.hhs.gov.

Sincerely,
/S/
John W. Diehl, M.S
Director, Compliance Branch
Office of Pharmaceutical Quality Operations, Division II