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REJUVENTUM, SA DE CV

⚠️ High Risk

FEI: 3006502076 • Ciudad De Mexico, Ciudad de Mexico • MEXICO

FEI

FEI Number

3006502076

📍

Location

Ciudad De Mexico, Ciudad de Mexico

🇲🇽

Country

MEXICO
🏢

Address

Calle Zaragoza No 1, Col. Cuajimalpa, Cuajimalpa De Morelos, Ciudad De Mexico, Ciudad de Mexico, Mexico

High Risk

FDA Import Risk Assessment

52.4
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

14
Total Refusals
5
Unique Violations
7/27/2016
Latest Refusal
2/6/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.6×40%
Refusal Volume
43.6×30%
Recency
0.0×20%
Frequency
31.3×10%
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

3109×

POISONOUS

The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.

754×

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).

1182×

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).

3132×

HELD INSAN

The cosmetic appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

3121×

FILTH

The cosmetic appears to consist in whole or in part of any filthy, putrid, or decomposed substance.

Refusal History

DateProductViolationsDivision
7/27/2016
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
310POISONOUS
New Orleans District Office (NOL-DO)
7/27/2016
53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS)
310POISONOUS
New Orleans District Office (NOL-DO)
7/27/2016
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
310POISONOUS
New Orleans District Office (NOL-DO)
7/27/2016
53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
310POISONOUS
New Orleans District Office (NOL-DO)
7/27/2016
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
310POISONOUS
New Orleans District Office (NOL-DO)
7/27/2016
53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
310POISONOUS
New Orleans District Office (NOL-DO)
7/27/2016
53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
310POISONOUS
New Orleans District Office (NOL-DO)
8/26/2014
53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS)
75UNAPPROVED
Southwest Import District Office (SWI-DO)
8/4/2014
53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS)
310POISONOUS
Florida District Office (FLA-DO)
1/14/2014
53LF01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
310POISONOUS
313HELD INSAN
Southwest Import District Office (SWI-DO)
8/29/2013
53LF01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
312FILTH
313HELD INSAN
Southwest Import District Office (SWI-DO)
6/22/2012
53LF01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
118NOT LISTED
75UNAPPROVED
Southwest Import District Office (SWI-DO)
6/22/2012
53LF01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
118NOT LISTED
75UNAPPROVED
Southwest Import District Office (SWI-DO)
2/6/2012
53LF01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is REJUVENTUM, SA DE CV's FDA import refusal history?

REJUVENTUM, SA DE CV (FEI: 3006502076) has 14 FDA import refusal record(s) in our database, spanning from 2/6/2012 to 7/27/2016.

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. REJUVENTUM, SA DE CV's FEI number is 3006502076.

What types of violations has REJUVENTUM, SA DE CV received?

REJUVENTUM, SA DE CV 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 REJUVENTUM, SA DE CV come from?

All FDA import refusal data for REJUVENTUM, SA DE CV 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.