Medicam Laboratories Dental Care Division
⚠️ Moderate Risk
FEI: 3008502338 • Unknown, Unknown • PAKISTAN
FEI Number
3008502338
Location
Unknown, Unknown
Country
PAKISTANAddress
Unknown, , Unknown, Unknown, Pakistan
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
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).
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.
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 |
|---|---|---|---|
| 2/3/2016 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 6/23/2011 | 63RBJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 11/4/2010 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Medicam Laboratories Dental Care Division's FDA import refusal history?
Medicam Laboratories Dental Care Division (FEI: 3008502338) has 3 FDA import refusal record(s) in our database, spanning from 11/4/2010 to 2/3/2016.
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. Medicam Laboratories Dental Care Division's FEI number is 3008502338.
What types of violations has Medicam Laboratories Dental Care Division received?
Medicam Laboratories Dental Care Division 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 Medicam Laboratories Dental Care Division come from?
All FDA import refusal data for Medicam Laboratories Dental Care Division 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.