Northeast Pharmaceutical Group Co., Ltd
⚠️ High Risk
FEI: 3012133741 • Shenyang, Liaoning • CHINA
FEI Number
3012133741
Location
Shenyang, Liaoning
Country
CHINAAddress
Economic Technology, No. 29 Shenxiliu Dong Road; Yuhong District, Shenyang, Liaoning, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
TAMPERING
It appears that the packing does not conform with current good manufacturing practices under 21 CFR 211.132 for tamper-resistant packaging.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/2/2015 | 54CBR23L-CARNITINE (PROTEIN) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 3/6/2012 | 54CYY23L-CARNITINE (PROTEIN) | 27DRUG GMPS | Los Angeles District Office (LOS-DO) |
| 1/11/2012 | 54CYY23L-CARNITINE (PROTEIN) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 8/24/2011 | 54ABT13VITAMIN C (ASCORBIC ACID) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/7/2011 | 54ABR13VITAMIN C (ASCORBIC ACID) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/3/2011 | 54ADS13VITAMIN C (ASCORBIC ACID) | 27DRUG GMPS | Los Angeles District Office (LOS-DO) |
| 2/24/2011 | 54ABZ13VITAMIN C (ASCORBIC ACID) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 2/18/2011 | 54ABR13VITAMIN C (ASCORBIC ACID) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/16/2010 | 54CBS23L-CARNITINE (PROTEIN) | 27DRUG GMPS | Seattle District Office (SEA-DO) |
| 11/17/2010 | 54AAR13VITAMIN C (ASCORBIC ACID) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 11/17/2010 | 54AAR13VITAMIN C (ASCORBIC ACID) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 11/17/2010 | 65CAR07LEVOCARNITINE (NUTRIENT/TONIC) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 11/17/2010 | 65CAR07LEVOCARNITINE (NUTRIENT/TONIC) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 10/26/2010 | 65CAR07LEVOCARNITINE (NUTRIENT/TONIC) | 115DR QUALITY | Los Angeles District Office (LOS-DO) |
| 9/17/2010 | 62VCS01AMANTADINE HCL (ANTI-VIRAL) | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 9/13/2010 | 65CAR07LEVOCARNITINE (NUTRIENT/TONIC) | 339TAMPERING | Los Angeles District Office (LOS-DO) |
| 9/13/2010 | 65CAR07LEVOCARNITINE (NUTRIENT/TONIC) | 290DE IMP GMP | Los Angeles District Office (LOS-DO) |
| 9/13/2010 | 65CAR07LEVOCARNITINE (NUTRIENT/TONIC) | 115DR QUALITY | Los Angeles District Office (LOS-DO) |
| 1/13/2009 | 62VCS01AMANTADINE HCL (ANTI-VIRAL) | 27DRUG GMPS | Southwest Import District Office (SWI-DO) |
| 10/29/2008 | 60SDZ26SUCRALFATE (ANTACID) | 27DRUG GMPS | Southwest Import District Office (SWI-DO) |
| 8/21/2008 | 54AFS13VITAMIN C (ASCORBIC ACID) | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 1/23/2008 | 56KCS10CHLORAMPHENICOL | 27DRUG GMPS | Philadelphia District Office (PHI-DO) |
| 10/17/2005 | 54ABR02VITAMIN B1 (THIAMINE) | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 1/12/2005 | 62VAS13RIMANTADINE HCL (ANTI-VIRAL) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 6/8/2004 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Northeast Pharmaceutical Group Co., Ltd's FDA import refusal history?
Northeast Pharmaceutical Group Co., Ltd (FEI: 3012133741) has 25 FDA import refusal record(s) in our database, spanning from 6/8/2004 to 2/2/2015.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Northeast Pharmaceutical Group Co., Ltd's FEI number is 3012133741.
What types of violations has Northeast Pharmaceutical Group Co., Ltd received?
Northeast Pharmaceutical Group Co., Ltd has been cited for 7 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Northeast Pharmaceutical Group Co., Ltd come from?
All FDA import refusal data for Northeast Pharmaceutical Group Co., Ltd is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.