CLOSEOUT LETTER
Seamus LLC
- Recipient:
- Seamus LLC
United States
- Issuing Office:
United States
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| Food and Drug Administration Baltimore District Office Central Region 6000 Metro Drive, Suite 101 Baltimore, MD 21215 Telephone: (410) 779-5455 FAX: (410) 779-5707 |
Department of Health and Human ServicesFEI: 3010099388
WARNING LETTER CLOSE-OUT LETTER
June 16, 2016
Via UPS
Mr. Young H. Han, CEO
Seamus LLC
6965 Gateway Ct.
Manassas, VA 20109
Dear Mr. Han:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 445104, dated May 20, 2015. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. A follow-up inspection performed by the FDA revealed that your firm has discontinued processing all eel products that were cited in the Warning Letter. Please inform the FDA in the event your firm decides to process any fishery products in the future.
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 yours,
David P. Rice
Compliance Officer
Baltimore District