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  5. Orangeburg Pecan Company Inc - 544396 - 12/20/2019
  1. Warning Letters

CLOSEOUT LETTER

Orangeburg Pecan Company Inc MARCS-CMS 544396 —

Product:
Food & Beverages
Recipient:
Recipient Name
Frederick J.D. Felder
Recipient Title
President
Orangeburg Pecan Company Inc

761 Russell St.
Orangeburg, SC 29115-5819
United States

Issuing Office:
Office of Human and Animal Foods- Division 3 East

United States

Dear Mr. Felder,

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning letter dated May 17, 2018. Based on our evaluation during the recent November 18-19, 2019 visit to your facility located at 11251 NC Highway 903, Halifax, NC 27839-9073, it appears that you have addressed the violation(s) contained in the 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 Janice L. King, Compliance Officer, U.S. Food and Drug Administration, 4600 Goer Drive, #106, North Charleston, SC 29406. You may also contact Ms. King at (843) 746-2990 x16 or via email at janice.king@fda.hhs.gov.

Sincerely,
/S/
Janice L. King
Compliance Officer
U.S. Food & Drug Adminisration
Office of Human and Animal Foods-Division 3 East
(Georgia- North Carolina-South Carolina)

Cc: Atlanta File- [Orangeburg Pecan-FEI: 1011345]

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