Colgate Oral Pharmaceuticals

⚠️ Moderate Risk

FEI: 2418748 • New York, NY • UNITED STATES

FEI

FEI Number

2418748

📍

Location

New York, NY

🇺🇸

Country

UNITED STATES

🏢

Address

300 Park Ave Fl 3, , New York, NY, United States

Moderate Risk

FDA Import Risk Assessment

39.8

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

8/13/2020

Latest Refusal

9/2/2003

Earliest Refusal

Score Breakdown

Violation Severity

54.8×40%

Refusal Volume

54.2×30%

Recency

0.0×20%

Frequency

16.5×10%

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

Violation Summary

11820×

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).

47310×

LABELING

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

167×

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.

755×

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).

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).

4711×

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.

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

1791×

AGR RX

The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.

Refusal History

Date	Product	Violations	Division
8/13/2020	63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)	118NOT LISTED	Division of Northern Border Imports (DNBI)
7/20/2020	63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)	118NOT LISTED 3280FRNMFGREG	Division of Northern Border Imports (DNBI)
9/22/2015	76EFWTOOTHBRUSH, MANUAL	341REGISTERED	New York District Office (NYK-DO)
2/3/2011	62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C.	16DIRECTIONS	New York District Office (NYK-DO)
8/21/2009	63RDY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)	179AGR RX	Southwest Import District Office (SWI-DO)
8/6/2008	63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)	118NOT LISTED	New York District Office (NYK-DO)
2/27/2008	63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
1/3/2007	63RAY99DENTAL CARIES PROPHYLACTIC N.E.C.	118NOT LISTED	New York District Office (NYK-DO)
1/3/2007	63RAY99DENTAL CARIES PROPHYLACTIC N.E.C.	118NOT LISTED	New York District Office (NYK-DO)
1/3/2007	63RAY99DENTAL CARIES PROPHYLACTIC N.E.C.	118NOT LISTED	New York District Office (NYK-DO)
10/24/2006	62WBR05ZIRCONIUM	118NOT LISTED 16DIRECTIONS 473LABELING	New York District Office (NYK-DO)
10/18/2006	62WBR05ZIRCONIUM	118NOT LISTED 16DIRECTIONS 473LABELING	New York District Office (NYK-DO)
10/10/2006	53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	473LABELING	New York District Office (NYK-DO)
10/10/2006	53JK02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	473LABELING	New York District Office (NYK-DO)
10/10/2006	53JI02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	473LABELING	New York District Office (NYK-DO)
10/10/2006	53JI02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	473LABELING	New York District Office (NYK-DO)
10/10/2006	62WBY05ZIRCONIUM	118NOT LISTED 16DIRECTIONS 473LABELING	New York District Office (NYK-DO)
10/10/2006	62WBY05ZIRCONIUM	118NOT LISTED 16DIRECTIONS 473LABELING	New York District Office (NYK-DO)
10/10/2006	62WBY05ZIRCONIUM	118NOT LISTED 16DIRECTIONS 473LABELING	New York District Office (NYK-DO)
10/10/2006	62WBY05ZIRCONIUM	118NOT LISTED 16DIRECTIONS 473LABELING	New York District Office (NYK-DO)
10/5/2006	76EFWTOOTHBRUSH, MANUAL	118NOT LISTED	New York District Office (NYK-DO)
10/5/2006	66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED	New York District Office (NYK-DO)
8/18/2006	63RAY99DENTAL CARIES PROPHYLACTIC N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/18/2006	63RAY99DENTAL CARIES PROPHYLACTIC N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/18/2006	63RAY99DENTAL CARIES PROPHYLACTIC N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/4/2006	66VAR99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/4/2006	66VAR99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED	New York District Office (NYK-DO)
9/2/2003	53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG	New York District Office (NYK-DO)

Frequently Asked Questions

What is Colgate Oral Pharmaceuticals's FDA import refusal history?

Colgate Oral Pharmaceuticals (FEI: 2418748) has 28 FDA import refusal record(s) in our database, spanning from 9/2/2003 to 8/13/2020.

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. Colgate Oral Pharmaceuticals's FEI number is 2418748.

What types of violations has Colgate Oral Pharmaceuticals received?

Colgate Oral Pharmaceuticals 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 Colgate Oral Pharmaceuticals come from?

All FDA import refusal data for Colgate Oral Pharmaceuticals 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.