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  5. Valley Proteins, Inc. - 582508 - 09/23/2021
  1. Warning Letters

CLOSEOUT LETTER

Valley Proteins, Inc. MARCS-CMS 582508 —

Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Curtis R. Robbins
Recipient Title
General Manager
Valley Proteins, Inc.

1635 Indian Hollow Road
Winchester, VA 22604-2586
United States

crobbins@valleyproteins.com
Issuing Office:
Division of Human and Animal Food Operations East II (HAFE2)

United States

410-779-5407
jessica.weber@fda.hhs.gov

Dear Mr. Robbins,

The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 582508, dated November 22, 2019. 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/
Jessica D. Weber
Compliance Officer
Baltimore District Office
Human & Animal Food East, Division 2
Office of Regulatory Affairs
U.S. Food and Drug Administration
T: 410-779-5407
M: 443-280-1276
jessica.weber@fda.hhs.gov


Cc (via email):

Firm:
Joan Kasprzycki-Strass, Quality Assurance Manager
(jkasprzyckistrauss@valleyproteins.com)

FDA:
Randy F. Pack, Program Division Director, District Director (randy.pack@fda.hhs.gov)
Natasha DeZinna, State Liaison (natasha.dezinna@fda.hhs.gov)
Robin M. Rivers, Director, Compliance Branch (robin.rivers@fda.hhs.gov)
Martin J. Guardia, Director, Investigations Branch (martin.guardia@fda.hhs.gov)
Margaret Torres-Vazquez, Supervisory Consumer Safety Officer (margaret.torres-vazquez@fda.hhs.gov)

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