Violation Code: 339
FDA Violation
Charge Code: TAMPERING
Violation Details
- Violation Code (ASC ID)
- 339
- Charge Code
- TAMPERING
- Description
- It appears that the packing does not conform with current good manufacturing practices under 21 CFR 211.132 for tamper-resistant packaging.
- Legal Section
- 501(a)(2)(B), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | GUANGDONG KEMEI PHARMACEUTICAL TECHNOLOGY CO LTD | Foshan, CHINA | 5 |
| 2 | Sun Pharmaceutical Industries (prev. Ranbaxy) | Dewas, INDIA | 3 |
| 3 | Desideri Flavia | Rome, ITALY | 1 |
| 4 | Cheong Chun Tong Medical Manufactory Inc. | Chai Wan, HONG KONG | 1 |
| 5 | Northeast Pharmaceutical Group Co., Ltd | Shenyang, CHINA | 1 |
| 6 | Guangzhou Shiruoni Cosmetics Co., Ltd | Guangzhou, CHINA | 1 |
| 7 | ESTRATEGIA HOSPITALARIA SA DE CV | Guadalajara, MEXICO | 1 |
| 8 | Pinewood Natural Health Centre | Toronto, CANADA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 2/26/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05 | |
| 2/26/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05 | |
| 2/26/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05 | |
| 2/26/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05 | |
| 2/26/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05 | |
| 2/23/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05 | |
| 12/9/2020 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05 | |
| 9/13/2010 | LEVOCARNITINE (NUTRIENT/TONIC) 65CAR07 | |
| 10/10/2008 | AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) 56BDA03 | |
| 10/10/2008 | AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) 56BCA03 | |
| 10/10/2008 | AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) 56BCR03 | |
| 4/20/2005 | SALICYLAMIDE (ANALGESIC) 60LAJ63 | |
| 8/18/2003 | VITAMIN, N.E.C. 54AYY99 | Desideri FlaviaITALY |
| 3/13/2003 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCP99 |
Related Violations
Other violations under the same legal section: 501(a)(2)(B), 801(a)(3); ADULTERATION
Frequently Asked Questions
What is FDA violation code 339?
339 is an FDA violation code that indicates: "It appears that the packing does not conform with current good manufacturing practices under 21 CFR 211.132 for tamper-resistant packaging.". This violation is based on 501(a)(2)(B), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 339?
According to FDA Import Refusal data, there have been 14 import refusals issued for violation code 339, affecting 8 unique firms.
When was the most recent refusal for violation 339?
The most recent import refusal for violation 339 was on February 26, 2021.
What products are commonly refused for violation 339?
Products commonly refused under violation 339 include: ETHYL ALCOHOL (ANTI-MICROBIAL). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 339?
Violation code 339 is based on 501(a)(2)(B), 801(a)(3); ADULTERATION 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.