Proctor & Gamble Hygiene And Health Care
⚠️ Moderate Risk
FEI: 3006686155 • Hyderabad, Telangana • INDIA
FEI Number
3006686155
Location
Hyderabad, Telangana
Country
INDIAAddress
9/5 & 6 Ida, , Hyderabad, Telangana, 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
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).
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/17/2016 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 2/28/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/1/2010 | 62MBY01CAMPHOR (ANTI-PRURITIC) | Division of Northern Border Imports (DNBI) | |
| 4/11/2006 | 77KCOINHALER, NASAL | New York District Office (NYK-DO) | |
| 2/8/2006 | 66VBY99MISCELLANEOUS 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 Proctor & Gamble Hygiene And Health Care's FDA import refusal history?
Proctor & Gamble Hygiene And Health Care (FEI: 3006686155) has 6 FDA import refusal record(s) in our database, spanning from 5/25/2005 to 2/17/2016.
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. Proctor & Gamble Hygiene And Health Care's FEI number is 3006686155.
What types of violations has Proctor & Gamble Hygiene And Health Care received?
Proctor & Gamble Hygiene And Health Care has been cited for 9 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 Proctor & Gamble Hygiene And Health Care come from?
All FDA import refusal data for Proctor & Gamble Hygiene And Health Care 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.