Industrias Cristian Lay Sa
⚠️ Moderate Risk
FEI: 3003487443 • Jerez Caballeros • SPAIN
FEI Number
3003487443
Location
Jerez Caballeros
Country
SPAINAddress
Ctra Badajoz S/N, , Jerez Caballeros, , Spain
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
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/17/2003 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 473LABELING | San Juan District Office (SJN-DO) |
| 6/17/2003 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 473LABELING | San Juan District Office (SJN-DO) |
| 6/17/2003 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 473LABELING | San Juan District Office (SJN-DO) |
| 6/17/2003 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 473LABELING | San Juan District Office (SJN-DO) |
| 6/17/2003 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 473LABELING | San Juan District Office (SJN-DO) |
| 6/17/2003 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 473LABELING | San Juan District Office (SJN-DO) |
| 6/17/2003 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 473LABELING | San Juan District Office (SJN-DO) |
| 6/17/2003 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | San Juan District Office (SJN-DO) |
| 6/13/2003 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/13/2003 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/13/2003 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/13/2003 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/13/2003 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/13/2003 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/13/2003 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Industrias Cristian Lay Sa's FDA import refusal history?
Industrias Cristian Lay Sa (FEI: 3003487443) has 15 FDA import refusal record(s) in our database, spanning from 6/13/2003 to 6/17/2003.
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. Industrias Cristian Lay Sa's FEI number is 3003487443.
What types of violations has Industrias Cristian Lay Sa received?
Industrias Cristian Lay Sa 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 Industrias Cristian Lay Sa come from?
All FDA import refusal data for Industrias Cristian Lay Sa 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.