Pearls of Beauty
⚠️ Moderate Risk
FEI: 3006657979 • Distt. Solan (H.P.) • INDIA
FEI Number
3006657979
Location
Distt. Solan (H.P.)
Country
INDIAAddress
28 Indl. Area Baddi, , Distt. Solan (H.P.), , India
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
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).
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).
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).
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 a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/18/2015 | 64XPR99KERATOLYTIC N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/18/2015 | 64XPR99KERATOLYTIC N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/18/2015 | 64XPR99KERATOLYTIC N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 2/6/2015 | 53FD02HAIR TINTS (HAIR COLORING PREPARATIONS) | 197COSM COLOR | Detroit District Office (DET-DO) |
| 2/6/2015 | 53FD02HAIR TINTS (HAIR COLORING PREPARATIONS) | 197COSM COLOR | Detroit District Office (DET-DO) |
| 9/15/2014 | 53FH99OTHER HAIR COLORING PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 11/30/2012 | 50NDY18HENNA | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 1/25/2012 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 197COSM COLOR | New England District Office (NWE-DO) |
| 10/14/2011 | 50NYY18HENNA | Southwest Import District Office (SWI-DO) | |
| 9/27/2011 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Detroit District Office (DET-DO) | |
| 3/8/2011 | 65LBR06CALAMINE (PROTECTANT) | New York District Office (NYK-DO) | |
| 8/18/2008 | 53FH02HAIR TINTS (HAIR COLORING PREPARATIONS) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 3/27/2008 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Pearls of Beauty's FDA import refusal history?
Pearls of Beauty (FEI: 3006657979) has 13 FDA import refusal record(s) in our database, spanning from 3/27/2008 to 6/18/2015.
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. Pearls of Beauty's FEI number is 3006657979.
What types of violations has Pearls of Beauty received?
Pearls of Beauty 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 Pearls of Beauty come from?
All FDA import refusal data for Pearls of Beauty 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.