Laboratorios Jaloma S.A. de C.V.
⚠️ High Risk
FEI: 3002600322 • Guadalajara, Jalisco • MEXICO
FEI Number
3002600322
Location
Guadalajara, Jalisco
Country
MEXICOAddress
Calle Aquiles Serdan No. 438, Col. Oblatos, Guadalajara, Guadalajara, Jalisco, Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
REDUCED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug that a substance has been mixed or packed with so as to reduce its strength.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/7/2023 | 66FDY99SUPPRESSANT N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/3/2022 | 62FCY14GENTIAN VIOLET (ANTI-INFECTIVE, TOPICAL) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/3/2022 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 3/3/2022 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/17/2022 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southwest Imports (DSWI) | |
| 2/17/2022 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southwest Imports (DSWI) | |
| 2/17/2022 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southwest Imports (DSWI) | |
| 6/9/2021 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/11/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/10/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/28/2017 | 62CDC65LISINOPRIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/4/2017 | 62CCH65LISINOPRIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2012 | 62FBL99ANTI-INFECTIVE, TOPICAL N.E.C. | 27DRUG GMPS | Southwest Import District Office (SWI-DO) |
| 11/5/2009 | 52EYY04PACIFIERS CONTAINING INGESTIBLE FOODS (E.G., HONEY), INFANT FOOD ITEMS | 251POISONOUS | Southwest Import District Office (SWI-DO) |
| 4/24/2006 | 53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/9/2003 | 53GC05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 475COSMETLBLG | Southwest Import District Office (SWI-DO) |
| 8/22/2003 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 12/2/2002 | 62FCK14GENTIAN VIOLET (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Laboratorios Jaloma S.A. de C.V.'s FDA import refusal history?
Laboratorios Jaloma S.A. de C.V. (FEI: 3002600322) has 18 FDA import refusal record(s) in our database, spanning from 12/2/2002 to 9/7/2023.
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 Jaloma S.A. de C.V.'s FEI number is 3002600322.
What types of violations has Laboratorios Jaloma S.A. de C.V. received?
Laboratorios Jaloma S.A. de C.V. has been cited for 10 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 Jaloma S.A. de C.V. come from?
All FDA import refusal data for Laboratorios Jaloma S.A. de C.V. 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.