Lab Por
⚠️ Moderate Risk
FEI: 3004083746 • Are • PERU
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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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).
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/5/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 218LIST INGRE | Los Angeles District Office (LOS-DO) |
| 4/13/2010 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/17/2009 | 61WBJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) | |
| 1/31/2009 | 54FBA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 472NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/31/2009 | 54FBA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 472NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/31/2009 | 54FBA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 472NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/31/2009 | 53JL01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 472NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/31/2009 | 53LC02DEPILATORIES (SKIN CARE PREPARATIONS) | 472NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/31/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 472NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/31/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 472NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/31/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 472NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/31/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 472NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/31/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 472NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/31/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 472NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/31/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 472NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/31/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 472NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/31/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 472NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/31/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/31/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 472NO ENGLISH | Los Angeles District Office (LOS-DO) |
| 1/31/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 1/31/2009 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 1/31/2009 | 54AFB99VITAMIN, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/12/2006 | 55RG99PHARMACEUTIC NECESSITIES, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Lab Por's FDA import refusal history?
Lab Por (FEI: 3004083746) has 23 FDA import refusal record(s) in our database, spanning from 6/12/2006 to 6/5/2012.
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. Lab Por's FEI number is 3004083746.
What types of violations has Lab Por received?
Lab Por has been cited for 5 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 Lab Por come from?
All FDA import refusal data for Lab Por 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.