Violation Code: 122
FDA Violation
Charge Code: ANTIBIOTIC
Violation Details
- Violation Code (ASC ID)
- 122
- Charge Code
- ANTIBIOTIC
- Description
- The drug appears to purport, or represented as, being composed wholly or partly of an antibiotic and it does not appear to be from a batch with respect to which a certificate or release has been issued pursuant to section 507. REPEALED11/97
- Legal Section
- 502(l), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Robson Honey & Supply Co | Phoenix, UNITED STA | 1 |
| 2 | Aurobindo Pharma Limited | Ameerpet, INDIA | 1 |
| 3 | Xi'An Fujie Bio-Tech Co., Ltd | Xian, CHINA | 1 |
| 4 | MEGACITY LLC | Moscow, RUSSIA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 6/4/2012 | HONEY 36CCP04 | MEGACITY LLCRUSSIA |
| 10/27/2006 | BEE POLLEN (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) 54YYA06 | Robson Honey & Supply CoUNITED STA |
| 11/17/2004 | ANTIBIOTIC N.E.C. 56YAR99 | |
| 8/2/2002 | AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) 56BYY07 |
Frequently Asked Questions
What is FDA violation code 122?
122 is an FDA violation code that indicates: "The drug appears to purport, or represented as, being composed wholly or partly of an antibiotic and it does not appear to be from a batch with respect to which a certificate or release has been issued pursuant to section 507. REPEALED11/97". This violation is based on 502(l), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 122?
According to FDA Import Refusal data, there have been 4 import refusals issued for violation code 122, affecting 4 unique firms.
When was the most recent refusal for violation 122?
The most recent import refusal for violation 122 was on June 4, 2012.
What products are commonly refused for violation 122?
Products commonly refused under violation 122 include: HONEY, BEE POLLEN (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.), ANTIBIOTIC N.E.C., AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 122?
Violation code 122 is based on 502(l), 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.