Ningbo Pulisi Daily Chemical Products Co., Ltd
⚠️ Moderate Risk
FEI: 3003727322 • Yuyao City, Zhejiang • CHINA
FEI Number
3003727322
Location
Yuyao City, Zhejiang
Country
CHINAAddress
Fangjia Road, Xiaocao'E Town, Yuyao City, Zhejiang, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
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).
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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.
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/18/2019 | 53JD99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 11/6/2019 | 53JD99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 8/16/2019 | 53JD99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/14/2019 | 62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 8/14/2019 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 8/14/2019 | 62HAY05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 8/14/2019 | 64AAK99DISINFECTANT N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 11/8/2018 | 62FBL99ANTI-INFECTIVE, TOPICAL N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 10/7/2013 | 64AAL99DISINFECTANT N.E.C. | Division of Northeast Imports (DNEI) | |
| 4/11/2013 | 55QY51ALCOHOL (PHARMACEUTIC NECESSITY - SOLVENT) | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 3/4/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Detroit District Office (DET-DO) | |
| 3/18/2009 | 62HAJ99ANTI-MICROBIAL N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/26/2005 | 62MAJ08MENTHOL (ANTI-PRURITIC) | Chicago District Office (CHI-DO) | |
| 10/26/2005 | 62MAY08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 6/14/2004 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Ningbo Pulisi Daily Chemical Products Co., Ltd's FDA import refusal history?
Ningbo Pulisi Daily Chemical Products Co., Ltd (FEI: 3003727322) has 15 FDA import refusal record(s) in our database, spanning from 6/14/2004 to 11/18/2019.
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. Ningbo Pulisi Daily Chemical Products Co., Ltd's FEI number is 3003727322.
What types of violations has Ningbo Pulisi Daily Chemical Products Co., Ltd received?
Ningbo Pulisi Daily Chemical Products Co., Ltd has been cited for 9 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 Ningbo Pulisi Daily Chemical Products Co., Ltd come from?
All FDA import refusal data for Ningbo Pulisi Daily Chemical Products 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.