CLOSEOUT LETTER
S.S.O., Inc dba BYS Company MARCS-CMS 496434 —
- Delivery Method:
- United Parcel Service
- Product:
- Food & Beverages
- Recipient:
-
Recipient NameJames W. Sims
-
Recipient TitlePresident
- S.S.O., Inc dba BYS Company
18273 Grand Ave.
#5&8
Lake Elsinore, CA 92530-6118
United States
- Issuing Office:
- Center for Food Safety and Nutrition
19701 Fairchild
Irvine, CA 92612
United States
Dear Mr. Sims:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 49-16 issued September 23, 2016 (CMS # 496434). 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.
Sincerely,
/S/
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
19701 Fairchild
Irvine, CA 92612