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Violation Code: 327

FDA Violation

Charge Code: OPTION ING

2
Total Refusals
2
Affected Firms
5/5/2017
Latest Case
8/6/2002
First Case

Violation Details

Violation Code (ASC ID)
327
Charge Code
OPTION ING
Description
It appears to be a food for which a definition and standard of identity have been prescribed by regulations under section 401 and appears to not be labelled with the common names of the optional ingredients specified therein.
Legal Section
403(g)(2), 801(a)(3); MISBRANDING

Most Affected Firms

#Firm NameLocationCases
1Meunerie Sawyerville IncCookshire, CANADA1
2Elementis GmbhCologne, GERMANY1

Recent Import Refusals

DateProductFirm
5/5/2017
BACITRACIN METHYLENE DISALICYLATE COMBO CATEGORY I & II, MEDICATED ANIMAL FEED
69CB07
8/6/2002
FOOD ADDITIVES FOR HUMAN USE, N.E.C.
46YC99

Related Violations

Other violations under the same legal section: 403(g)(2), 801(a)(3); MISBRANDING

CodeCharge CodeCases
325STD NAME152

Frequently Asked Questions

What is FDA violation code 327?

327 is an FDA violation code that indicates: "It appears to be a food for which a definition and standard of identity have been prescribed by regulations under section 401 and appears to not be labelled with the common names of the optional ingredients specified therein.". This violation is based on 403(g)(2), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 327?

According to FDA Import Refusal data, there have been 2 import refusals issued for violation code 327, affecting 2 unique firms.

When was the most recent refusal for violation 327?

The most recent import refusal for violation 327 was on May 5, 2017.

What products are commonly refused for violation 327?

Products commonly refused under violation 327 include: BACITRACIN METHYLENE DISALICYLATE COMBO CATEGORY I & II, MEDICATED ANIMAL FEED, FOOD ADDITIVES FOR HUMAN USE, N.E.C.. These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 327?

Violation code 327 is based on 403(g)(2), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section of the law establishes requirements that imported products must meet to be allowed entry into the United States.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.