CLOSEOUT LETTER
Saffron Health Sciences MARCS-CMS 615429 —
- Delivery Method:
- Next Day Air
- Product:
- Dietary Supplements
- Recipient:
-
Recipient NameDr. Song Gao
- Saffron Health Sciences
13 Dexter Rd
E Brunswick, NJ 08816-2873
United States-
- natureway62@gmail.com
- Issuing Office:
- Division of Human and Animal Food Operations East II
United States
Dear Dr. Gao;
The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS #615429, dated November 18, 2021. 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 further regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Andrew Howard
Consumer Safety Officer/Compliance Officer
Office of Human and Animal Food East II
Baltimore District Office
U.S. Food and Drug Administration
Tel: 410-779-5125
Andrew.Howard@fda.hhs.gov