J C Laboratory
⚠️ Moderate Risk
FEI: 3008345478 • Cavite • PHILIPPINES
FEI Number
3008345478
Location
Cavite
Country
PHILIPPINESAddress
Sta Isabel Kawitd Plada, , Cavite, , Philippines
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
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).
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.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/11/2010 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Seattle District Office (SEA-DO) |
| 6/11/2010 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 6/11/2010 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 6/11/2010 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 6/11/2010 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 6/11/2010 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 16DIRECTIONS | Seattle District Office (SEA-DO) |
| 6/11/2010 | 64LAJ37HYDROCORTISONE (GLUCOCORTICOID) | 16DIRECTIONS | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is J C Laboratory's FDA import refusal history?
J C Laboratory (FEI: 3008345478) has 7 FDA import refusal record(s) in our database, spanning from 6/11/2010 to 6/11/2010.
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. J C Laboratory's FEI number is 3008345478.
What types of violations has J C Laboratory received?
J C Laboratory has been cited for 3 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 J C Laboratory come from?
All FDA import refusal data for J C Laboratory 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.