Inspections, Compliance, Enforcement, and Criminal Investigations

Warning Letters

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Select the year from the list above in which the warning letter was issued, and browse the chronological list of warning letters on the linked page.

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More Information about Warning Letters Posted Here
- Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.
- To obtain available additional information on the current status of an issue in a particular warning letter on this site, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at How to Make a FOIA Request.
Recently Posted Warning Letters

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
January 10, 2017	Hawaiian Ono Services, Inc.	San Francisco District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *
January 10, 2017	Aspen Hills, Inc.	Kansas City District Office	CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes	Not Issued *
January 06, 2017	Sato Yakuhin Kogyo Co., Ltd.	Center for Drug Evaluation and Research	CGMP/Finished Pharmaceuticals/Adulterated	Not Issued *
January 06, 2017	Suzhou Pharmaceutical Technology Co.,Ltd	Center for Drug Evaluation and Research	CGMP/Active Pharmaceutical Ingredient (API)/Adulterated	Not Issued *
December 23, 2016	Horizon Pharmaceuticals, Inc.	Florida District Office	CGMP/Finished Pharmaceuticals/Adulterated	Not Issued *
December 22, 2016	Florida Key West, Inc.	Florida District Office	Juice/HACCP/Adulterated	Not Issued *
December 22, 2016	Northern Health Products	Atlanta District Office	Unapproved New Drugs/Misbranded	Not Issued *
December 08, 2016	Pharm D Solutions, LLC	Dallas District Office	Compounding Pharmacy/Adulterated Drug Products	Not Issued *
December 07, 2016	Esteem Products LTD	Seattle District Office	Internet Marketing of Unapproved and Misbranded Drugs	Not Issued *

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857