- FACTA Farmaceutici S.p.A.
10903 New Hampshire Avenue
Silver Spring, MD 20993
August 25, 2017
Quality Unit Director
FACTA Farmaceutici S.p.A.
Nucleo Ind. Le S. Atto
San Nicolo a Tordino 64100 (TE), Italy
Reference: Warning Letter 320-17-17
Location: FACTA Farmaceutici S.p.A.
Zona Industriale Sant’ Atto S N
Terramo, Teramo, 64100, Italy
Dear Mr. Gullua:
The Food and Drug Administration has completed an evaluation of FACTA Farmaceutici S.p.A. (FEI 3006028606) corrective actions in response to Warning Letter 320-17-17, dated January 01, 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 any questions regarding this letter, you may contact me at the above address or number: (301) 796-5339.
For more information on the U.S. FDA, please visit our website at www.fda.gov.
Cesar E. Matto
Division of Drug Quality