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Refinette Cosmetic Industry

⚠️ Moderate Risk

FEI: 3005424393 • Manila • PHILIPPINES

FEI

FEI Number

3005424393

📍

Location

Manila

🇵🇭
🏢

Address

Unknown Street, , Manila, , Philippines

Moderate Risk

FDA Import Risk Assessment

39.4
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

15
Total Refusals
3
Unique Violations
3/1/2006
Latest Refusal
3/1/2006
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
44.6×30%
Recency
0.0×20%
Frequency
100.0×10%
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

47114×

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.

1181×

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).

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
3/1/2006
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
3/1/2006
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
3/1/2006
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
3/1/2006
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
3/1/2006
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
3/1/2006
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
3/1/2006
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
3/1/2006
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
3/1/2006
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
3/1/2006
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
3/1/2006
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
3/1/2006
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
3/1/2006
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
3/1/2006
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
3/1/2006
80FMINEEDLE, HYPODERMIC, SINGLE LUMEN
118NOT LISTED
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Refinette Cosmetic Industry's FDA import refusal history?

Refinette Cosmetic Industry (FEI: 3005424393) has 15 FDA import refusal record(s) in our database, spanning from 3/1/2006 to 3/1/2006.

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. Refinette Cosmetic Industry's FEI number is 3005424393.

What types of violations has Refinette Cosmetic Industry received?

Refinette Cosmetic Industry has been cited for 3 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 Refinette Cosmetic Industry come from?

All FDA import refusal data for Refinette Cosmetic Industry 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.