Violation Code: 3847
FDA Violation
Charge Code: FDF4APIGMP
Violation Details
- Violation Code (ASC ID)
- 3847
- Charge Code
- FDF4APIGMP
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods and controls used in its manufacture and control do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B). This finished dosage form drug is made using an Active Pharmaceutical Ingredient from a facility that has been found non-compliant with current Good Manufacturing Practice (see Import Alert 66-40; http://www.accessdata.fda.gov/cms_ia/importalert_189.html). You may submit testimony to provide evidence to overcome the appearance of adulteration. The API source for this finished dosage form drug is:
- Legal Section
- 501(a)(2)(B), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | AstraZeneca AB | Sodertalje, SWEDEN | 12 |
| 2 | Laboratories La Prairie Sa | Volketswil, SWITZERLAN | 8 |
| 3 | Baxter Heathcare Ltd | Thetford, UNITED KIN | 3 |
| 4 | Glenmark Pharmaceuticals Limited | Colvale, INDIA | 2 |
| 5 | Padagis Israel Pharmaceuticals Ltd. | Yerucham, ISRAEL | 2 |
| 6 | Allergan Pharmaceuticals Ireland | Westport, IRELAND | 1 |
| 7 | AstraZeneca AB | Sodertalje, SWEDEN | 1 |
| 8 | Ipca Laboratories Limited | Ratlam, INDIA | 1 |
| 9 | Sc Farmec Sa | Cluj-napoca, ROMANIA | 1 |
| 10 | WHITMAN LABORATORIES LTD. | Petersfield, UNITED KIN | 1 |
| 11 | STRIDES ARCOLAB LIMITED | Mumbai, INDIA | 1 |
| 12 | Unilever Uk Home & Personal Caredeodorants Sourcing Unit | Leeds, UNITED KIN | 1 |
| 13 | Zhejiang Ludao Technology Co., Ltd. | Taizhou, CHINA | 1 |
| 14 | Ningbo Unichem Bio Technology Co., Ltd. | Ningbo, CHINA | 1 |
| 15 | RPG Life Sciences Limited | Ankleshwar, INDIA | 1 |
| 16 | Carlos Segundo Floril Cruz | Policentro, ECUADOR | 1 |
| 17 | DEMOPHORIOUS LTD. | Limassol, CYPRUS | 1 |
| 18 | The Estee Lauder Inc. | Melville, UNITED STA | 1 |
| 19 | UNILEVER DE ARGENTINA SA | Tortuguitas, ARGENTINA | 1 |
| 20 | Estee Lauder Cosmetics Ltd. | Scarborough, CANADA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 11/24/2020 | DIPHENOXYLATE HCL (ANTI-PERISTALTIC) 62KDY03 | |
| 2/8/2019 | DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JK02 | |
| 2/15/2018 | CALCIUM GLUCONATE (REPLENISHER) 65RCP04 | Baxter Heathcare LtdUNITED KIN |
| 2/15/2018 | CALCIUM GLUCONATE (REPLENISHER) 65RCP04 | Baxter Heathcare LtdUNITED KIN |
| 2/15/2018 | CALCIUM GLUCONATE (REPLENISHER) 65RCP04 | Baxter Heathcare LtdUNITED KIN |
| 1/17/2018 | BOTOX 65QBY02 | |
| 8/8/2017 | BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE 57YH02 | DEMOPHORIOUS LTD.CYPRUS |
| 2/23/2017 | DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JA02 | |
| 2/23/2017 | DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JA02 | UNILEVER DE ARGENTINA SAARGENTINA |
| 6/14/2016 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LD03 | Laboratories La Prairie SaSWITZERLAN |
| 6/14/2016 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LD03 | Laboratories La Prairie SaSWITZERLAN |
| 6/14/2016 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LD03 | Laboratories La Prairie SaSWITZERLAN |
| 6/14/2016 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LY03 | Laboratories La Prairie SaSWITZERLAN |
| 6/14/2016 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LY03 | Laboratories La Prairie SaSWITZERLAN |
| 6/14/2016 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LC03 | Laboratories La Prairie SaSWITZERLAN |
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 3847?
3847 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods and controls used in its manufacture and control do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B). This finished dosage form drug is made using an Active Pharmaceutical Ingredient from a facility that has been found non-compliant with current Good Manufacturing Practice (see Import Alert 66-40; http://www.accessdata.fda.gov/cms_ia/importalert_189.html). You may submit testimony to provide evidence to overcome the appearance of adulteration. The API source for this finished dosage form drug is:". 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 3847?
According to FDA Import Refusal data, there have been 43 import refusals issued for violation code 3847, affecting 21 unique firms.
When was the most recent refusal for violation 3847?
The most recent import refusal for violation 3847 was on November 24, 2020.
What products are commonly refused for violation 3847?
Products commonly refused under violation 3847 include: DIPHENOXYLATE HCL (ANTI-PERISTALTIC), DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS), CALCIUM GLUCONATE (REPLENISHER). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3847?
Violation code 3847 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.