Procter & Gamble Hygiene and Health Care Limited
⚠️ Moderate Risk
FEI: 3005081951 • Ponda, Goa • INDIA
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).
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.
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).
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).
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.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/18/2025 | 85HHLPAD, MENSTRUAL, SCENTED | Division of Southwest Imports (DSWI) | |
| 7/18/2025 | 85HHLPAD, MENSTRUAL, SCENTED | Division of Southwest Imports (DSWI) | |
| 7/18/2025 | 85HHLPAD, MENSTRUAL, SCENTED | Division of Southwest Imports (DSWI) | |
| 2/8/2006 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 2/8/2006 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 5/25/2005 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Procter & Gamble Hygiene and Health Care Limited's FDA import refusal history?
Procter & Gamble Hygiene and Health Care Limited (FEI: 3005081951) has 6 FDA import refusal record(s) in our database, spanning from 5/25/2005 to 7/18/2025.
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 Hygiene and Health Care Limited's FEI number is 3005081951.
What types of violations has Procter & Gamble Hygiene and Health Care Limited received?
Procter & Gamble Hygiene and Health Care Limited 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 Hygiene and Health Care Limited come from?
All FDA import refusal data for Procter & Gamble Hygiene and Health Care Limited 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.