Lab Ofichem B.V.
⚠️ Moderate Risk
FEI: 1000286391 • Ter Apel, Groningen • NETHERLANDS
FEI Number
1000286391
Location
Ter Apel, Groningen
Country
NETHERLANDSAddress
Heembadweg 5, , Ter Apel, Groningen, Netherlands
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
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).
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.
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 |
|---|---|---|---|
| 4/6/2009 | 64TIR03LEVAMISOLE HYDROCHLORIDE (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/31/2002 | 61GCS48SULFADIAZINE SODIUM (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 72NEW VET DR | New York District Office (NYK-DO) |
| 1/22/2002 | 61GCS48SULFADIAZINE SODIUM (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 27DRUG GMPS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Lab Ofichem B.V.'s FDA import refusal history?
Lab Ofichem B.V. (FEI: 1000286391) has 3 FDA import refusal record(s) in our database, spanning from 1/22/2002 to 4/6/2009.
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. Lab Ofichem B.V.'s FEI number is 1000286391.
What types of violations has Lab Ofichem B.V. received?
Lab Ofichem B.V. 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 Lab Ofichem B.V. come from?
All FDA import refusal data for Lab Ofichem B.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.