Central Naturista De Baja California Sa De Cv
⚠️ Moderate Risk
FEI: 1000587999 • Tijuana, B.C. • MEXICO
FEI Number
1000587999
Location
Tijuana, B.C.
Country
MEXICOAddress
Av Revolucion No 1993, , Tijuana, B.C., Mexico
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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(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).
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 |
|---|---|---|---|
| 1/20/2005 | 53AC02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 7/30/2003 | 55QY32LANOLIN (PHARMACEUTIC NECESSITY - WATER IN OIL EMULSION) | Southwest Import District Office (SWI-DO) | |
| 7/30/2003 | 60LAL99ANALGESIC, N.E.C. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Central Naturista De Baja California Sa De Cv's FDA import refusal history?
Central Naturista De Baja California Sa De Cv (FEI: 1000587999) has 3 FDA import refusal record(s) in our database, spanning from 7/30/2003 to 1/20/2005.
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. Central Naturista De Baja California Sa De Cv's FEI number is 1000587999.
What types of violations has Central Naturista De Baja California Sa De Cv received?
Central Naturista De Baja California Sa De Cv 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 Central Naturista De Baja California Sa De Cv come from?
All FDA import refusal data for Central Naturista De Baja California Sa De Cv 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.