Cristian Lay S.A.
⚠️ Moderate Risk
FEI: 3002794698 • Espana • SPAIN
FEI Number
3002794698
Location
Espana
Country
SPAINAddress
Cta. Badajoz, S/N., Jerez De Los, , Badajoz, Espana, , 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
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).
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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 |
|---|---|---|---|
| 6/18/2009 | 53LK02DEPILATORIES (SKIN CARE PREPARATIONS) | 197COSM COLOR | San Juan District Office (SJN-DO) |
| 8/10/2007 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 8/10/2007 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 8/10/2007 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 8/9/2007 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | San Juan District Office (SJN-DO) | |
| 8/9/2007 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 8/9/2007 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 8/9/2007 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 8/9/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 8/9/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 8/9/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 6/26/2007 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Juan District Office (SJN-DO) | |
| 6/26/2007 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 6/26/2007 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 8/27/2003 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/13/2003 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/13/2003 | 66YBJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/13/2003 | 66YBJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Cristian Lay S.A.'s FDA import refusal history?
Cristian Lay S.A. (FEI: 3002794698) has 18 FDA import refusal record(s) in our database, spanning from 6/13/2003 to 6/18/2009.
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. Cristian Lay S.A.'s FEI number is 3002794698.
What types of violations has Cristian Lay S.A. received?
Cristian Lay S.A. 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 Cristian Lay S.A. come from?
All FDA import refusal data for Cristian Lay S.A. 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.