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Laboratorios Rangel S.R.L.

⚠️ High Risk

FEI: 3005000080 • Cibao Central, La Vega • DOMINICAN REPUBLIC

FEI

FEI Number

3005000080

📍

Location

Cibao Central, La Vega

🇩🇴
🏢

Address

Principal Street No.15, Residencial Santa Maria, Cibao Central, La Vega, Dominican Republic

High Risk

FDA Import Risk Assessment

52.3
LowModerateHighCritical

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

Statistics

28
Total Refusals
8
Unique Violations
9/20/2013
Latest Refusal
8/27/2008
Earliest Refusal

Score Breakdown

Violation Severity
76.3×40%
Refusal Volume
54.2×30%
Recency
0.0×20%
Frequency
55.2×10%
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

7511×

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).

166×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

115×

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).

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.

2742×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

3302×

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).

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

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).

Refusal History

DateProductViolationsDivision
9/20/2013
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
473LABELING
San Juan District Office (SJN-DO)
12/9/2011
66VAA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/9/2011
66VAA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/9/2011
66VAA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/9/2011
66VAA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/9/2011
66VAA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
9/19/2008
66VAL99MISCELLANEOUS PATENT MEDICINES, ETC.
330UNSAFE COL
Division of Northeast Imports (DNEI)
9/19/2008
54BCL99MINERAL N.E.C.
274COLOR LBLG
Division of Northeast Imports (DNEI)
9/19/2008
54BCL99MINERAL N.E.C.
274COLOR LBLG
Division of Northeast Imports (DNEI)
9/19/2008
54BCL99MINERAL N.E.C.
260FALSE
Division of Northeast Imports (DNEI)
9/19/2008
54BCL99MINERAL N.E.C.
260FALSE
Division of Northeast Imports (DNEI)
9/19/2008
62FAL20IODINE (ANTI-INFECTIVE, TOPICAL)
118NOT LISTED
75UNAPPROVED
Division of Northeast Imports (DNEI)
9/19/2008
66FBL99SUPPRESSANT N.E.C.
75UNAPPROVED
Division of Northeast Imports (DNEI)
9/19/2008
62FAL20IODINE (ANTI-INFECTIVE, TOPICAL)
75UNAPPROVED
Division of Northeast Imports (DNEI)
9/19/2008
62FBL14GENTIAN VIOLET (ANTI-INFECTIVE, TOPICAL)
75UNAPPROVED
Division of Northeast Imports (DNEI)
9/19/2008
61HAL99ANTI-BACTERIAL, N.E.C.
75UNAPPROVED
Division of Northeast Imports (DNEI)
9/19/2008
66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
16DIRECTIONS
330UNSAFE COL
Division of Northeast Imports (DNEI)
9/19/2008
66VAL99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
Division of Northeast Imports (DNEI)
9/19/2008
66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
16DIRECTIONS
Division of Northeast Imports (DNEI)
9/19/2008
66VAL99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
Division of Northeast Imports (DNEI)
9/19/2008
66VAL99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
Division of Northeast Imports (DNEI)
9/19/2008
53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
11UNSAFE COL
Division of Northeast Imports (DNEI)
9/19/2008
54BCL99MINERAL N.E.C.
11UNSAFE COL
Division of Northeast Imports (DNEI)
9/19/2008
54BBL99MINERAL N.E.C.
11UNSAFE COL
Division of Northeast Imports (DNEI)
9/19/2008
54BBL99MINERAL N.E.C.
11UNSAFE COL
Division of Northeast Imports (DNEI)
9/19/2008
53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.
11UNSAFE COL
Division of Northeast Imports (DNEI)
8/27/2008
66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Division of Northeast Imports (DNEI)
8/27/2008
61RBY07METHYLENE BLUE (ANTIDOTE)
16DIRECTIONS
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Laboratorios Rangel S.R.L.'s FDA import refusal history?

Laboratorios Rangel S.R.L. (FEI: 3005000080) has 28 FDA import refusal record(s) in our database, spanning from 8/27/2008 to 9/20/2013.

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. Laboratorios Rangel S.R.L.'s FEI number is 3005000080.

What types of violations has Laboratorios Rangel S.R.L. received?

Laboratorios Rangel S.R.L. has been cited for 8 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 Laboratorios Rangel S.R.L. come from?

All FDA import refusal data for Laboratorios Rangel S.R.L. 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.