Laboratorios Ordonez Sa De Cv
⚠️ Moderate Risk
FEI: 3003516557 • Mexicomexico • MEXICO
FEI Number
3003516557
Location
Mexicomexico
Country
MEXICOAddress
Norte 23-A # 46, , Mexicomexico, , 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
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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.
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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/4/2014 | 60LK99ANALGESIC, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 9/4/2014 | 60LK99ANALGESIC, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 4/9/2013 | 68CBO20ANTISEPTIC USED MORE THAN 1 SPECIES | Southwest Import District Office (SWI-DO) | |
| 4/9/2013 | 68CBO20ANTISEPTIC USED MORE THAN 1 SPECIES | Southwest Import District Office (SWI-DO) | |
| 5/21/2012 | 62GPJ99ANTI-INFLAMMATORY N.E.C. | Southwest Import District Office (SWI-DO) | |
| 5/21/2012 | 62GPJ99ANTI-INFLAMMATORY N.E.C. | Southwest Import District Office (SWI-DO) | |
| 5/21/2012 | 62GPJ99ANTI-INFLAMMATORY N.E.C. | Southwest Import District Office (SWI-DO) | |
| 5/21/2012 | 62GPJ99ANTI-INFLAMMATORY N.E.C. | Southwest Import District Office (SWI-DO) | |
| 9/18/2007 | 68CDJ20ANTISEPTIC USED MORE THAN 1 SPECIES | Southwest Import District Office (SWI-DO) | |
| 9/18/2007 | 68CDJ20ANTISEPTIC USED MORE THAN 1 SPECIES | Southwest Import District Office (SWI-DO) | |
| 6/27/2003 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | Chicago District Office (CHI-DO) | |
| 8/20/2002 | 68KBJ20WOUND DRESSING USED MORE THAN 1 SPECIES | 72NEW VET DR | Southwest Import District Office (SWI-DO) |
| 8/20/2002 | 68KBJ20WOUND DRESSING USED MORE THAN 1 SPECIES | 72NEW VET DR | Southwest Import District Office (SWI-DO) |
| 6/24/2002 | 68KBJ20WOUND DRESSING USED MORE THAN 1 SPECIES | 72NEW VET DR | Southwest Import District Office (SWI-DO) |
| 6/24/2002 | 68KBJ20WOUND DRESSING USED MORE THAN 1 SPECIES | 72NEW VET DR | Southwest Import District Office (SWI-DO) |
| 4/9/2002 | 68KBJ20WOUND DRESSING USED MORE THAN 1 SPECIES | 72NEW VET DR | Southwest Import District Office (SWI-DO) |
| 4/9/2002 | 68KBJ20WOUND DRESSING USED MORE THAN 1 SPECIES | 72NEW VET DR | Southwest Import District Office (SWI-DO) |
| 3/7/2002 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 12/28/2001 | 68CBJ20ANTISEPTIC USED MORE THAN 1 SPECIES | Southwest Import District Office (SWI-DO) | |
| 12/28/2001 | 68CBJ20ANTISEPTIC USED MORE THAN 1 SPECIES | Southwest Import District Office (SWI-DO) | |
| 11/27/2001 | 68CBJ20ANTISEPTIC USED MORE THAN 1 SPECIES | Southwest Import District Office (SWI-DO) | |
| 11/27/2001 | 68CBJ20ANTISEPTIC USED MORE THAN 1 SPECIES | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Laboratorios Ordonez Sa De Cv's FDA import refusal history?
Laboratorios Ordonez Sa De Cv (FEI: 3003516557) has 22 FDA import refusal record(s) in our database, spanning from 11/27/2001 to 9/4/2014.
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. Laboratorios Ordonez Sa De Cv's FEI number is 3003516557.
What types of violations has Laboratorios Ordonez Sa De Cv received?
Laboratorios Ordonez Sa De Cv has been cited for 6 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 Laboratorios Ordonez Sa De Cv come from?
All FDA import refusal data for Laboratorios Ordonez 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.