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Crystalderm Skin Care Corp.

⚠️ Moderate Risk

FEI: 3005115970 • Rizal, Calabarzon • PHILIPPINES

FEI

FEI Number

3005115970

📍

Location

Rizal, Calabarzon

🇵🇭
🏢

Address

101 Darangan, , Rizal, Calabarzon, Philippines

Moderate Risk

FDA Import Risk Assessment

36.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
3
Unique Violations
2/16/2011
Latest Refusal
2/16/2011
Earliest Refusal

Score Breakdown

Violation Severity
62.5×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

2602×

FALSE

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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

751×

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).

Refusal History

DateProductViolationsDivision
2/16/2011
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
260FALSE
Los Angeles District Office (LOS-DO)
2/16/2011
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
260FALSE
Los Angeles District Office (LOS-DO)
2/16/2011
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
223FALSE
Los Angeles District Office (LOS-DO)
2/16/2011
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Crystalderm Skin Care Corp.'s FDA import refusal history?

Crystalderm Skin Care Corp. (FEI: 3005115970) has 4 FDA import refusal record(s) in our database, spanning from 2/16/2011 to 2/16/2011.

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. Crystalderm Skin Care Corp.'s FEI number is 3005115970.

What types of violations has Crystalderm Skin Care Corp. received?

Crystalderm Skin Care Corp. 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 Crystalderm Skin Care Corp. come from?

All FDA import refusal data for Crystalderm Skin Care Corp. 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.