Intradevco Industrial Sa

⚠️ Moderate Risk

FEI: 3004418783 • Lima • PERU

FEI

FEI Number

3004418783

📍

Location

Lima

🇵🇪

Country

PERU

🏢

Address

Av Productos Nacionales 188, , Lima, , Peru

Moderate Risk

FDA Import Risk Assessment

39.9

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/23/2015

Latest Refusal

6/16/2004

Earliest Refusal

Score Breakdown

Violation Severity

56.3×40%

Refusal Volume

51.1×30%

Recency

0.0×20%

Frequency

20.9×10%

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

11819×

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).

7510×

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).

3416×

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).

4723×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

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.

3301×

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).

Refusal History

Date	Product	Violations	Division
6/23/2015	76EFWTOOTHBRUSH, MANUAL	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	76EFWTOOTHBRUSH, MANUAL	118NOT LISTED 341REGISTERED	Division of Southeast Imports (DSEI)
6/23/2015	53JD99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C.	118NOT LISTED 75UNAPPROVED	Division of Southeast Imports (DSEI)
6/23/2015	53JD99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C.	118NOT LISTED 75UNAPPROVED	Division of Southeast Imports (DSEI)
6/23/2015	53JD99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C.	118NOT LISTED 75UNAPPROVED	Division of Southeast Imports (DSEI)
6/23/2015	53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)	118NOT LISTED 75UNAPPROVED	Division of Southeast Imports (DSEI)
6/23/2015	53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)	118NOT LISTED 75UNAPPROVED	Division of Southeast Imports (DSEI)
6/23/2015	53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)	118NOT LISTED 75UNAPPROVED	Division of Southeast Imports (DSEI)
6/23/2015	53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)	75UNAPPROVED	Division of Southeast Imports (DSEI)
7/10/2014	66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 3280FRNMFGREG 330UNSAFE COL 75UNAPPROVED	Florida District Office (FLA-DO)
7/10/2014	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	118NOT LISTED	Division of Southeast Imports (DSEI)
7/10/2014	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	118NOT LISTED	Division of Southeast Imports (DSEI)
7/10/2014	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	118NOT LISTED	Division of Southeast Imports (DSEI)
7/10/2014	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	118NOT LISTED	Division of Southeast Imports (DSEI)
7/10/2014	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	75UNAPPROVED	Division of Southeast Imports (DSEI)
7/10/2014	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	75UNAPPROVED	Division of Southeast Imports (DSEI)
2/21/2013	76EFWTOOTHBRUSH, MANUAL	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
2/21/2013	76EFWTOOTHBRUSH, MANUAL	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
2/21/2013	76EFWTOOTHBRUSH, MANUAL	118NOT LISTED 341REGISTERED	New York District Office (NYK-DO)
10/14/2008	76EFWTOOTHBRUSH, MANUAL	341REGISTERED	Florida District Office (FLA-DO)
10/14/2008	65LBL11TITANIUM DIOXIDE (PROTECTANT)	118NOT LISTED 472NO ENGLISH	Florida District Office (FLA-DO)
10/14/2008	62MBJ08MENTHOL (ANTI-PRURITIC)	118NOT LISTED 472NO ENGLISH	Florida District Office (FLA-DO)
6/16/2004	63RBY99DENTAL CARIES PROPHYLACTIC N.E.C.	118NOT LISTED 472NO ENGLISH	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Intradevco Industrial Sa's FDA import refusal history?

Intradevco Industrial Sa (FEI: 3004418783) has 23 FDA import refusal record(s) in our database, spanning from 6/16/2004 to 6/23/2015.

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. Intradevco Industrial Sa's FEI number is 3004418783.

What types of violations has Intradevco Industrial Sa received?

Intradevco Industrial Sa has been cited for 6 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 Intradevco Industrial Sa come from?

All FDA import refusal data for Intradevco Industrial Sa 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.