Procter & Gamble De Mexico
⚠️ Moderate Risk
FEI: 3003982345 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3003982345
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Privada Loma Florida 32, Col. Lomas De Vista Hermosa, Cuajimalpa De Morelos, Ciudad De Mexico, Ciudad de Mexico, 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.
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).
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. 801.15(c)(1)
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/13/2021 | 60SAK06BISMUTH (ANTACID) | Division of Southeast Imports (DSEI) | |
| 1/13/2021 | 60SAK06BISMUTH (ANTACID) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/13/2021 | 60SAK06BISMUTH (ANTACID) | Division of Southeast Imports (DSEI) | |
| 12/17/2019 | 62MBJ01CAMPHOR (ANTI-PRURITIC) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 9/12/2012 | 85NRCPADS, MENSTRUAL, SCENTED-DEODORIZED | Southwest Import District Office (SWI-DO) | |
| 11/13/2007 | 85HHDPAD, MENSTRUAL, UNSCENTED | 341REGISTERED | Southwest Import District Office (SWI-DO) |
| 11/13/2007 | 85HHLPAD, MENSTRUAL, SCENTED | 341REGISTERED | Southwest Import District Office (SWI-DO) |
| 11/13/2007 | 85HHDPAD, MENSTRUAL, UNSCENTED | 341REGISTERED | Southwest Import District Office (SWI-DO) |
| 11/13/2007 | 85HHDPAD, MENSTRUAL, UNSCENTED | 341REGISTERED | Southwest Import District Office (SWI-DO) |
| 10/15/2004 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 1/22/2004 | 62SAL99ANTI-SEBORRHEIC N.E.C. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 1/22/2004 | 62SAL99ANTI-SEBORRHEIC N.E.C. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 1/22/2004 | 62SAL99ANTI-SEBORRHEIC N.E.C. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 1/14/2004 | 62SBL99ANTI-SEBORRHEIC N.E.C. | Southwest Import District Office (SWI-DO) | |
| 1/14/2004 | 62SBL99ANTI-SEBORRHEIC N.E.C. | Southwest Import District Office (SWI-DO) | |
| 1/14/2004 | 62SBL99ANTI-SEBORRHEIC N.E.C. | Southwest Import District Office (SWI-DO) | |
| 1/14/2004 | 62SBL99ANTI-SEBORRHEIC N.E.C. | Southwest Import District Office (SWI-DO) | |
| 1/14/2004 | 62SBL99ANTI-SEBORRHEIC N.E.C. | Southwest Import District Office (SWI-DO) | |
| 1/14/2004 | 62SBL99ANTI-SEBORRHEIC N.E.C. | Southwest Import District Office (SWI-DO) | |
| 6/4/2003 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Southwest Import District Office (SWI-DO) | |
| 10/15/2002 | 53EG03HAIR STRAIGHTENERS (HAIR PREPARATIONS, NON-COLORING) | 473LABELING | Southwest Import District Office (SWI-DO) |
| 8/29/2002 | 62MBY08MENTHOL (ANTI-PRURITIC) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Procter & Gamble De Mexico's FDA import refusal history?
Procter & Gamble De Mexico (FEI: 3003982345) has 22 FDA import refusal record(s) in our database, spanning from 8/29/2002 to 3/13/2021.
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 De Mexico's FEI number is 3003982345.
What types of violations has Procter & Gamble De Mexico received?
Procter & Gamble De Mexico 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 Procter & Gamble De Mexico come from?
All FDA import refusal data for Procter & Gamble De Mexico 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.