Century Pharmaceuticals Limited
⚠️ High Risk
FEI: 3004999635 • Halol, Gujarat • INDIA
FEI Number
3004999635
Location
Halol, Gujarat
Country
INDIAAddress
103 - 106 Gidc, , Halol, 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
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.
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.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/27/2025 | 65PIY02SILDENAFIL CITRATE (REGULATOR) | 3845DRG REF EI | Division of Southeast Imports (DSEI) |
| 11/2/2022 | 56LOY20ERYTHROMYCIN PHOSPHATE (NON-CERTIFIABLE) | Division of Southeast Imports (DSEI) | |
| 11/16/2020 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/4/2018 | 56KQT11CHLORAMPHENICOL PALMITATE | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Century Pharmaceuticals Limited's FDA import refusal history?
Century Pharmaceuticals Limited (FEI: 3004999635) has 4 FDA import refusal record(s) in our database, spanning from 9/4/2018 to 10/27/2025.
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. Century Pharmaceuticals Limited's FEI number is 3004999635.
What types of violations has Century Pharmaceuticals Limited received?
Century Pharmaceuticals 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 Century Pharmaceuticals Limited come from?
All FDA import refusal data for Century Pharmaceuticals 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.