Laboratory Mck
⚠️ Moderate Risk
FEI: 3005190388 • Mexico • 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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/12/2023 | 64LDY06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/21/2008 | 60SDB04ALUMINUM HYDROXIDE (ANTACID) | 331DR QUALITC | New Orleans District Office (NOL-DO) |
| 12/21/2008 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 331DR QUALITC | New Orleans District Office (NOL-DO) |
| 12/21/2008 | 63HDB06CASCARA (CATHARTIC) | 331DR QUALITC | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laboratory Mck's FDA import refusal history?
Laboratory Mck (FEI: 3005190388) has 4 FDA import refusal record(s) in our database, spanning from 12/21/2008 to 5/12/2023.
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. Laboratory Mck's FEI number is 3005190388.
What types of violations has Laboratory Mck received?
Laboratory Mck has been cited for 2 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 Laboratory Mck come from?
All FDA import refusal data for Laboratory Mck 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.