Medical Products Laboratories, Inc.
⚠️ Moderate Risk
FEI: 2513595 • Philadelphia, PA • UNITED STATES
FEI Number
2513595
Location
Philadelphia, PA
Country
UNITED STATESAddress
9990 Global Rd, , Philadelphia, PA, United States
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).
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/14/2012 | 75MRVDRINK, GLUCOSE TOLERANCE | New York District Office (NYK-DO) | |
| 11/13/2012 | 63RCJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/2/2012 | 75MRVDRINK, GLUCOSE TOLERANCE | 508NO 510(K) | Philadelphia District Office (PHI-DO) |
| 11/3/2011 | 60QDJ56BENZOCAINE (ANESTHETIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/12/2009 | 63RCQ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/12/2009 | 63RCQ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/12/2009 | 63RCJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/12/2009 | 60QDJ56BENZOCAINE (ANESTHETIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/12/2009 | 60QDJ56BENZOCAINE (ANESTHETIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/1/2007 | 60QDJ56BENZOCAINE (ANESTHETIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Medical Products Laboratories, Inc.'s FDA import refusal history?
Medical Products Laboratories, Inc. (FEI: 2513595) has 10 FDA import refusal record(s) in our database, spanning from 8/1/2007 to 11/14/2012.
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. Medical Products Laboratories, Inc.'s FEI number is 2513595.
What types of violations has Medical Products Laboratories, Inc. received?
Medical Products Laboratories, Inc. 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 Medical Products Laboratories, Inc. come from?
All FDA import refusal data for Medical Products Laboratories, Inc. 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.