CHI PHARMACEUTICALS LTD.
⚠️ Moderate Risk
FEI: 3013314099 • Lagos, Lagos State • NIGERIA
FEI Number
3013314099
Location
Lagos, Lagos State
Country
NIGERIAAddress
Chivita Avenue, 14 Ajao Rd., Lagos, Lagos State, Nigeria
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
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
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 PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/21/2024 | 09GGT15YOGURT (PLAIN, FLAVORED OR FRUIT ADDED), SHEEP MILK | Division of Northeast Imports (DNEI) | |
| 9/30/2024 | 09CHT05MILK, FLAVORED (CHOCOLATE, ETC.) | Division of Northeast Imports (DNEI) | |
| 5/20/2024 | 54FEL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 482NUTRIT LBL | Division of Northeast Imports (DNEI) |
| 4/24/2019 | 61GDY57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is CHI PHARMACEUTICALS LTD.'s FDA import refusal history?
CHI PHARMACEUTICALS LTD. (FEI: 3013314099) has 4 FDA import refusal record(s) in our database, spanning from 4/24/2019 to 11/21/2024.
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. CHI PHARMACEUTICALS LTD.'s FEI number is 3013314099.
What types of violations has CHI PHARMACEUTICALS LTD. received?
CHI PHARMACEUTICALS LTD. 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 CHI PHARMACEUTICALS LTD. come from?
All FDA import refusal data for CHI PHARMACEUTICALS 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.