Plasticos y Materias Primas, S.A. de C.V.

⚠️ Moderate Risk

FEI: 3002710954 • Guadalajara, Jalisco • MEXICO

FEI

FEI Number

3002710954

📍

Location

Guadalajara, Jalisco

🇲🇽

Country

MEXICO

🏢

Address

Juan De La Barrera No. 3609-2, Zona Industrial Parque Industrial El Alamo, Guadalajara, Guadalajara, Jalisco, Mexico

Moderate Risk

FDA Import Risk Assessment

44.8

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

3/9/2017

Latest Refusal

12/19/2016

Earliest Refusal

Score Breakdown

Violation Severity

73.5×40%

Refusal Volume

31.3×30%

Recency

0.0×20%

Frequency

60.0×10%

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

Violation Summary

1266×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

4796×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

27805×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

Refusal History

Date	Product	Violations	Division
3/9/2017	80LHISET, I.V. FLUID TRANSER	126FAILS STD 2780DEVICEGMPS 479DV QUALITY	Division of Southwest Imports (DSWI)
2/24/2017	80LHISET, I.V. FLUID TRANSER	126FAILS STD 2780DEVICEGMPS 479DV QUALITY	Division of Southwest Imports (DSWI)
2/24/2017	80LHISET, I.V. FLUID TRANSER	126FAILS STD 2780DEVICEGMPS 479DV QUALITY	Division of Southwest Imports (DSWI)
2/3/2017	80LHISET, I.V. FLUID TRANSER	126FAILS STD 2780DEVICEGMPS 479DV QUALITY	Division of Southwest Imports (DSWI)
2/3/2017	80LHISET, I.V. FLUID TRANSER	126FAILS STD 2780DEVICEGMPS 479DV QUALITY	Division of Southwest Imports (DSWI)
12/19/2016	80LHISET, I.V. FLUID TRANSER	126FAILS STD 479DV QUALITY	Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is Plasticos y Materias Primas, S.A. de C.V.'s FDA import refusal history?

Plasticos y Materias Primas, S.A. de C.V. (FEI: 3002710954) has 6 FDA import refusal record(s) in our database, spanning from 12/19/2016 to 3/9/2017.

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. Plasticos y Materias Primas, S.A. de C.V.'s FEI number is 3002710954.

What types of violations has Plasticos y Materias Primas, S.A. de C.V. received?

Plasticos y Materias Primas, S.A. de C.V. 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 Plasticos y Materias Primas, S.A. de C.V. come from?

All FDA import refusal data for Plasticos y Materias Primas, S.A. de C.V. 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.