Shering Plough
⚠️ Moderate Risk
FEI: 3008431878 • Memphis, TN • UNITED STATES
FEI Number
3008431878
Location
Memphis, TN
Country
UNITED STATESAddress
P O Box 305, , Memphis, TN, 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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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 |
|---|---|---|---|
| 10/22/2010 | 53LA04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/22/2010 | 79KMFBANDAGE, LIQUID | Florida District Office (FLA-DO) | |
| 9/22/2010 | 80KYSINSOLES, MEDICAL | Florida District Office (FLA-DO) | |
| 9/22/2010 | 80KYSINSOLES, MEDICAL | Florida District Office (FLA-DO) | |
| 9/22/2010 | 80KYSINSOLES, MEDICAL | Florida District Office (FLA-DO) | |
| 9/22/2010 | 80KYSINSOLES, MEDICAL | Florida District Office (FLA-DO) | |
| 9/22/2010 | 80KYSINSOLES, MEDICAL | Florida District Office (FLA-DO) | |
| 9/22/2010 | 80KYSINSOLES, MEDICAL | Florida District Office (FLA-DO) | |
| 9/22/2010 | 80KYSINSOLES, MEDICAL | Florida District Office (FLA-DO) | |
| 9/22/2010 | 64XBY06SALICYLIC ACID (KERATOLYTIC) | Florida District Office (FLA-DO) | |
| 9/22/2010 | 53LA04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 56GBQ99ANTIFUNGAL N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 64XBL06SALICYLIC ACID (KERATOLYTIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 56GBQ99ANTIFUNGAL N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 56GBQ99ANTIFUNGAL N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 80KYSINSOLES, MEDICAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 80KYSINSOLES, MEDICAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 80KYSINSOLES, MEDICAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 80KYSINSOLES, MEDICAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/22/2010 | 53LA04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/22/2010 | 53LC04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Shering Plough's FDA import refusal history?
Shering Plough (FEI: 3008431878) has 21 FDA import refusal record(s) in our database, spanning from 9/22/2010 to 10/22/2010.
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. Shering Plough's FEI number is 3008431878.
What types of violations has Shering Plough received?
Shering Plough 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 Shering Plough come from?
All FDA import refusal data for Shering Plough 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.