Procter and Gamble Manufactura S. de R.L. de C.V.
⚠️ Moderate Risk
FEI: 3004444900 • Caleras De Obrajuelo, Guanajuato • MEXICO
FEI Number
3004444900
Location
Caleras De Obrajuelo, Guanajuato
Country
MEXICOAddress
Carretera Queretaro Celaya Km 16, , Caleras De Obrajuelo, Guanajuato, Mexico
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
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.
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.
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/24/2017 | 61HAJ05ZINC PYRITHIONE (ANTI-BACTERIAL) | Division of Southwest Imports (DSWI) | |
| 8/24/2017 | 61HAL05ZINC PYRITHIONE (ANTI-BACTERIAL) | Division of Southwest Imports (DSWI) | |
| 5/19/2017 | 61HAL05ZINC PYRITHIONE (ANTI-BACTERIAL) | Division of Southwest Imports (DSWI) | |
| 5/13/2010 | 61WAL99A-FUNGAL N.E.C. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 5/13/2010 | 61WAL99A-FUNGAL N.E.C. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Procter and Gamble Manufactura S. de R.L. de C.V.'s FDA import refusal history?
Procter and Gamble Manufactura S. de R.L. de C.V. (FEI: 3004444900) has 5 FDA import refusal record(s) in our database, spanning from 5/13/2010 to 8/24/2017.
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. Procter and Gamble Manufactura S. de R.L. de C.V.'s FEI number is 3004444900.
What types of violations has Procter and Gamble Manufactura S. de R.L. de C.V. received?
Procter and Gamble Manufactura S. de R.L. de C.V. 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 Procter and Gamble Manufactura S. de R.L. de C.V. come from?
All FDA import refusal data for Procter and Gamble Manufactura S. de R.L. 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.