Gillette Diversified Operations Private Limited
⚠️ High Risk
FEI: 3016116902 • Ahmedabad, Gujarat • INDIA
FEI Number
3016116902
Location
Ahmedabad, Gujarat
Country
INDIAAddress
Plot no. SM-46, GIDC BOL (Sanand-II) Industrial Estate, , Ahmedabad, Gujarat, India
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).
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.
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/31/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 7/31/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 7/3/2025 | 62MDY01CAMPHOR (ANTI-PRURITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/11/2025 | 62MBY01CAMPHOR (ANTI-PRURITIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 6/11/2025 | 62MBY01CAMPHOR (ANTI-PRURITIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/21/2025 | 62MBY08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/1/2025 | 77KCOINHALER, NASAL | Division of Northern Border Imports (DNBI) | |
| 3/5/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 2/12/2025 | 66FBY99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/15/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 9/27/2024 | 62UBY99ANTI-TUSSIVE/COLD N.E.C. | Division of Northeast Imports (DNEI) | |
| 9/20/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/20/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 7/17/2024 | 62MBP01CAMPHOR (ANTI-PRURITIC) | Division of Northeast Imports (DNEI) | |
| 6/4/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 4/29/2024 | 62MAJ08MENTHOL (ANTI-PRURITIC) | Division of Northeast Imports (DNEI) | |
| 3/29/2024 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/16/2024 | 62MBJ08MENTHOL (ANTI-PRURITIC) | Division of Northeast Imports (DNEI) | |
| 12/27/2023 | 62MBJ01CAMPHOR (ANTI-PRURITIC) | Division of Northeast Imports (DNEI) | |
| 2/24/2023 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 2/24/2023 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 2/6/2023 | 62MBO01CAMPHOR (ANTI-PRURITIC) | 336INCONSPICU | Division of Southeast Imports (DSEI) |
| 2/6/2023 | 62MBO01CAMPHOR (ANTI-PRURITIC) | 336INCONSPICU | Division of Southeast Imports (DSEI) |
| 2/6/2023 | 62MBO01CAMPHOR (ANTI-PRURITIC) | 336INCONSPICU | Division of Southeast Imports (DSEI) |
| 3/15/2021 | 65SBJ99RUBEFACIENT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/8/2021 | 77KCOINHALER, NASAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Gillette Diversified Operations Private Limited's FDA import refusal history?
Gillette Diversified Operations Private Limited (FEI: 3016116902) has 26 FDA import refusal record(s) in our database, spanning from 3/8/2021 to 7/31/2025.
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. Gillette Diversified Operations Private Limited's FEI number is 3016116902.
What types of violations has Gillette Diversified Operations Private Limited received?
Gillette Diversified Operations Private Limited has been cited for 5 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 Gillette Diversified Operations Private Limited come from?
All FDA import refusal data for Gillette Diversified Operations Private 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.