Gregory Pharmaceutical Holdings Inc. dba UPM Pharmaceuticals Inc.
⚠️ Moderate Risk
FEI: 1000208638 • Bristol, TN • UNITED STATES
FEI Number
1000208638
Location
Bristol, TN
Country
UNITED STATESAddress
501 5th St, , Bristol, 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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 1/12/2024 | 56FBK30POLYMYXIN B SULFATE (PEPTIDES) | Division of Northern Border Imports (DNBI) | |
| 1/6/2012 | 56BCK52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 1/18/2006 | 62GIA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/4/2005 | 66JDB01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 179AGR RX | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Gregory Pharmaceutical Holdings Inc. dba UPM Pharmaceuticals Inc.'s FDA import refusal history?
Gregory Pharmaceutical Holdings Inc. dba UPM Pharmaceuticals Inc. (FEI: 1000208638) has 4 FDA import refusal record(s) in our database, spanning from 10/4/2005 to 1/12/2024.
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. Gregory Pharmaceutical Holdings Inc. dba UPM Pharmaceuticals Inc.'s FEI number is 1000208638.
What types of violations has Gregory Pharmaceutical Holdings Inc. dba UPM Pharmaceuticals Inc. received?
Gregory Pharmaceutical Holdings Inc. dba UPM Pharmaceuticals Inc. has been cited for 4 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 Gregory Pharmaceutical Holdings Inc. dba UPM Pharmaceuticals Inc. come from?
All FDA import refusal data for Gregory Pharmaceutical Holdings Inc. dba UPM Pharmaceuticals 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.