Procter & Gamble Hygiene and Health Care Ltd.
⚠️ Moderate Risk
FEI: 3008614345 • 173205 Solan H.P • INDIA
FEI Number
3008614345
Location
173205 Solan H.P
Country
INDIAAddress
Katha, P.O. Baddi, 173205 Solan H.P, , 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).
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.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/12/2016 | 54YEJ99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 16DIRECTIONS | San Francisco District Office (SAN-DO) |
| 2/12/2016 | 62UBJ99ANTI-TUSSIVE/COLD N.E.C. | 16DIRECTIONS | San Francisco District Office (SAN-DO) |
| 1/30/2013 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/2/2012 | 60LBJ07CAMPHORATED OIL | Chicago District Office (CHI-DO) | |
| 12/21/2010 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 12/21/2010 | 66VNS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Procter & Gamble Hygiene and Health Care Ltd.'s FDA import refusal history?
Procter & Gamble Hygiene and Health Care Ltd. (FEI: 3008614345) has 6 FDA import refusal record(s) in our database, spanning from 12/21/2010 to 2/12/2016.
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. Procter & Gamble Hygiene and Health Care Ltd.'s FEI number is 3008614345.
What types of violations has Procter & Gamble Hygiene and Health Care Ltd. received?
Procter & Gamble Hygiene and Health Care Ltd. has been cited for 4 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 Ltd. come from?
All FDA import refusal data for Procter & Gamble Hygiene and Health Care Ltd. 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.