Rdl Cosmetics Laboratory Inc
⚠️ Moderate Risk
FEI: 3006222866 • Davao City • PHILIPPINES
FEI Number
3006222866
Location
Davao City
Country
PHILIPPINESAddress
Davao, , Davao City, , Philippines
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
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/31/2012 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 7/31/2012 | 64XDL12TRETINOIN (KERATOLYTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/31/2012 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/31/2012 | 65LAJ99PROTECTANT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/22/2008 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 1/22/2008 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 1/16/2008 | 63VCJ02HYDROQUINONE (DEPIGMENTOR) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 11/20/2007 | 63VAL99DEPIGMENTOR N.E.C. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Rdl Cosmetics Laboratory Inc's FDA import refusal history?
Rdl Cosmetics Laboratory Inc (FEI: 3006222866) has 8 FDA import refusal record(s) in our database, spanning from 11/20/2007 to 7/31/2012.
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. Rdl Cosmetics Laboratory Inc's FEI number is 3006222866.
What types of violations has Rdl Cosmetics Laboratory Inc received?
Rdl Cosmetics Laboratory Inc has been cited for 4 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 Rdl Cosmetics Laboratory Inc come from?
All FDA import refusal data for Rdl Cosmetics Laboratory Inc 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.