Procter & Gamble Manufactura S.de R.L.de CV
⚠️ High Risk
FEI: 3011254861 • Mexico, DF • MEXICO
FEI Number
3011254861
Location
Mexico, DF
Country
MEXICOAddress
Poniente 146 #850 Ind.Vallejo, Ave.San Rafael#7, Mexico, DF, Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/12/2025 | 62GDY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 9/24/2025 | 62UDY11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/16/2017 | 61HAL05ZINC PYRITHIONE (ANTI-BACTERIAL) | Division of Southwest Imports (DSWI) | |
| 5/16/2017 | 61HAL05ZINC PYRITHIONE (ANTI-BACTERIAL) | Division of Southwest Imports (DSWI) | |
| 5/16/2017 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Division of Southwest Imports (DSWI) | |
| 5/16/2017 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Division of Southwest Imports (DSWI) | |
| 7/29/2012 | 62MBL99ANTI-PRURITIC N.E.C. | Southwest Import District Office (SWI-DO) | |
| 7/29/2012 | 62MBL99ANTI-PRURITIC N.E.C. | Southwest Import District Office (SWI-DO) | |
| 7/29/2012 | 62MBL99ANTI-PRURITIC N.E.C. | Southwest Import District Office (SWI-DO) | |
| 7/29/2012 | 62MBL99ANTI-PRURITIC N.E.C. | Southwest Import District Office (SWI-DO) | |
| 4/15/2009 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Procter & Gamble Manufactura S.de R.L.de CV's FDA import refusal history?
Procter & Gamble Manufactura S.de R.L.de CV (FEI: 3011254861) has 11 FDA import refusal record(s) in our database, spanning from 4/15/2009 to 12/12/2025.
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 & Gamble Manufactura S.de R.L.de CV's FEI number is 3011254861.
What types of violations has Procter & Gamble Manufactura S.de R.L.de CV received?
Procter & Gamble Manufactura S.de R.L.de CV has been cited for 7 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 & Gamble Manufactura S.de R.L.de CV come from?
All FDA import refusal data for Procter & Gamble Manufactura S.de R.L.de CV 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.