Cheryl Laboratories Pvt Ltd
⚠️ High Risk
FEI: 3010165197 • Navi Mumbai, Maharashtra • INDIA
FEI Number
3010165197
Location
Navi Mumbai, Maharashtra
Country
INDIAAddress
Plot No: 328, 329 330 Ttc Industrial Area, Navi Mumbai, Maharashtra, 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
DRG REF EI
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
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).
REFUSE EI
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/5/2025 | 54AFY16VITAMIN E (TOCOPHEROL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/22/2024 | 62CDO41MINOXIDIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/5/2024 | 62FAY18ICHTHAMMOL (ANTI-INFECTIVE, TOPICAL) | 3845DRG REF EI | Division of Southeast Imports (DSEI) |
| 7/5/2024 | 62CAY41MINOXIDIL (ANTI-HYPERTENSIVE) | 3845DRG REF EI | Division of Southeast Imports (DSEI) |
| 12/8/2023 | 66PDJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/3/2023 | 61WBK36SALICYLANILIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 3/17/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3845DRG REF EI | Division of Southeast Imports (DSEI) |
| 3/17/2023 | 62CDY41MINOXIDIL (ANTI-HYPERTENSIVE) | 3845DRG REF EI | Division of Southeast Imports (DSEI) |
| 12/16/2021 | 61PDY26METFORMIN (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 7/15/2021 | 62JCY15PRAMIPEXOLE (ANTI-PARKINSONIAN) | 3600REFUSE EI | Division of Southeast Imports (DSEI) |
| 6/8/2021 | 62CCL41MINOXIDIL (ANTI-HYPERTENSIVE) | Division of Southeast Imports (DSEI) | |
| 8/19/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Cheryl Laboratories Pvt Ltd's FDA import refusal history?
Cheryl Laboratories Pvt Ltd (FEI: 3010165197) has 12 FDA import refusal record(s) in our database, spanning from 8/19/2020 to 5/5/2025.
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. Cheryl Laboratories Pvt Ltd's FEI number is 3010165197.
What types of violations has Cheryl Laboratories Pvt Ltd received?
Cheryl Laboratories Pvt 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 Cheryl Laboratories Pvt Ltd come from?
All FDA import refusal data for Cheryl Laboratories Pvt 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.