GL Biochem (Shanghai) Ltd
⚠️ High Risk
FEI: 3007554486 • Shanghai, Shanghai • CHINA
FEI Number
3007554486
Location
Shanghai, Shanghai
Country
CHINAAddress
519 Zi Yue Road, , Shanghai, Shanghai, 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
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).
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.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/3/2025 | 56FDR99PEPTIDE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/22/2022 | 75JKDRADIOIMMUNOASSAY, C-PEPTIDES OF PROINSULIN | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/1/2022 | 57VI99IN-VITRO DIAG PRODUCTS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/28/2022 | 56FIY99PEPTIDE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/24/2022 | 55YY99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 2280DIRSEXMPT | Division of West Coast Imports (DWCI) |
| 12/23/2021 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2021 | 56FAY99PEPTIDE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/1/2021 | 56FIY99PEPTIDE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/28/2021 | 66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/12/2021 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/3/2020 | 88PPMGENERAL PURPOSE REAGENT | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/7/2020 | 83OTTRESEARCH USE ONLY/MICROBIOLOGY | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2020 | 56FYY99PEPTIDE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/13/2020 | 56FYY99PEPTIDE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/12/2020 | 88PPMGENERAL PURPOSE REAGENT | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/22/2019 | 56FIY99PEPTIDE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/16/2019 | 56FYY99PEPTIDE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/30/2018 | 56FYY99PEPTIDE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2018 | 88PPMGENERAL PURPOSE REAGENT | Division of Southeast Imports (DSEI) | |
| 9/8/2017 | 56FAY99PEPTIDE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2016 | 56FYY99PEPTIDE N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/16/2014 | 56FYY99PEPTIDE N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/10/2014 | 56FAY99PEPTIDE N.E.C. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 8/15/2014 | 56FYY99PEPTIDE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/17/2014 | 56FYY99PEPTIDE N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/17/2014 | 88LDTREAGENT, GENERAL PURPOSE | Los Angeles District Office (LOS-DO) | |
| 4/4/2014 | 56FXY99PEPTIDE N.E.C. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 2/25/2014 | 56FYY99PEPTIDE N.E.C. | Cincinnati District Office (CIN-DO) | |
| 2/13/2014 | 56FYY99PEPTIDE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/13/2014 | 56FYY99PEPTIDE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/2/2014 | 56FYY99PEPTIDE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/18/2013 | 56FYY99PEPTIDE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/30/2013 | 56FYY99PEPTIDE N.E.C. | Seattle District Office (SEA-DO) | |
| 6/19/2012 | 56FYY99PEPTIDE N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/30/2008 | 56FYY99PEPTIDE N.E.C. | Seattle District Office (SEA-DO) | |
| 12/30/2008 | 56FYY99PEPTIDE N.E.C. | Seattle District Office (SEA-DO) | |
| 7/22/2008 | 56FYY99PEPTIDE N.E.C. | Seattle District Office (SEA-DO) | |
| 7/3/2008 | 56FYY99PEPTIDE N.E.C. | Seattle District Office (SEA-DO) | |
| 7/2/2008 | 56FXY99PEPTIDE N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 6/23/2008 | 56FYY99PEPTIDE N.E.C. | Seattle District Office (SEA-DO) | |
| 4/15/2008 | 56FYY99PEPTIDE N.E.C. | Seattle District Office (SEA-DO) | |
| 4/15/2008 | 56FYY99PEPTIDE N.E.C. | Seattle District Office (SEA-DO) | |
| 4/1/2008 | 56FYY99PEPTIDE N.E.C. | Seattle District Office (SEA-DO) | |
| 3/25/2008 | 56FYY99PEPTIDE N.E.C. | Seattle District Office (SEA-DO) | |
| 3/25/2008 | 56FYY99PEPTIDE N.E.C. | Seattle District Office (SEA-DO) | |
| 6/5/2007 | 56FYY99PEPTIDE N.E.C. | Seattle District Office (SEA-DO) | |
| 3/12/2007 | 56FYY99PEPTIDE N.E.C. | 16DIRECTIONS | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is GL Biochem (Shanghai) Ltd's FDA import refusal history?
GL Biochem (Shanghai) Ltd (FEI: 3007554486) has 47 FDA import refusal record(s) in our database, spanning from 3/12/2007 to 7/3/2025.
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. GL Biochem (Shanghai) Ltd's FEI number is 3007554486.
What types of violations has GL Biochem (Shanghai) Ltd received?
GL Biochem (Shanghai) Ltd has been cited for 11 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 GL Biochem (Shanghai) Ltd come from?
All FDA import refusal data for GL Biochem (Shanghai) 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.