Catalent Pharma Solutions, LLC
⚠️ High Risk
FEI: 1811396 • Saint Petersburg, FL • UNITED STATES
FEI Number
1811396
Location
Saint Petersburg, FL
Country
UNITED STATESAddress
2725 Scherer Dr N, , Saint Petersburg, FL, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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).
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/19/2017 | 65JCH31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2017 | 61JCH99ANTI-CHOLESTEREMIC, N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/14/2016 | 65JCH31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/14/2016 | 65JCH31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/15/2016 | 61JCH99ANTI-CHOLESTEREMIC, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/15/2016 | 61WAM18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/15/2016 | 61WAM18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/15/2016 | 65JAH31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/15/2016 | 65JAH31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/15/2016 | 62GAH41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/15/2016 | 65JCH31PROGESTERONE (PROGESTIN) | 27DRUG GMPS | Florida District Office (FLA-DO) |
| 8/15/2016 | 62AAH04CALCITRIOL (ANTI-HYPERCALCEMIC) | 27DRUG GMPS | Florida District Office (FLA-DO) |
| 8/15/2016 | 65JCH31PROGESTERONE (PROGESTIN) | 27DRUG GMPS | Florida District Office (FLA-DO) |
| 8/15/2016 | 61WAM18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 27DRUG GMPS | Florida District Office (FLA-DO) |
| 7/20/2016 | 61JCH99ANTI-CHOLESTEREMIC, N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/20/2016 | 61WAM18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 7/20/2016 | 61WAM18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 7/20/2016 | 62GAH41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/20/2016 | 65JCH31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/20/2016 | 65JCH31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2016 | 65JAH31PROGESTERONE (PROGESTIN) | Florida District Office (FLA-DO) | |
| 6/23/2016 | 65JAH31PROGESTERONE (PROGESTIN) | Florida District Office (FLA-DO) | |
| 6/23/2016 | 62GAH41IBUPROFEN (ANTI-INFLAMMATORY) | Florida District Office (FLA-DO) | |
| 6/23/2016 | 62AAH04CALCITRIOL (ANTI-HYPERCALCEMIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/23/2016 | 65JAH31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/23/2016 | 65JAH31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/23/2016 | 65JCH31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/23/2016 | 61WAM18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/23/2016 | 62GAH41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/23/2016 | 62AAH04CALCITRIOL (ANTI-HYPERCALCEMIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/23/2016 | 65JCH31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/23/2016 | 61WAM18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/23/2016 | 65JCH31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/23/2016 | 65JCH31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/23/2016 | 62GAH41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/23/2016 | 65JCH31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/23/2016 | 65JCH31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/23/2016 | 62GAH41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/22/2016 | 65JAH31PROGESTERONE (PROGESTIN) | Florida District Office (FLA-DO) | |
| 6/22/2016 | 65JAH31PROGESTERONE (PROGESTIN) | Florida District Office (FLA-DO) | |
| 6/22/2016 | 61WAM18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/22/2016 | 62AAH04CALCITRIOL (ANTI-HYPERCALCEMIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/22/2016 | 61WAM18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/22/2016 | 62GAH41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/10/2016 | 61WAM18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/10/2016 | 65JAH31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/10/2016 | 65JAH31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/10/2016 | 62GAH41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/2/2016 | 62GAH41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/12/2007 | 62UAH11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 223FALSE | New York District Office (NYK-DO) |
| 12/12/2007 | 62UAH11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | New York District Office (NYK-DO) | |
| 11/28/2007 | 62UAH11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 223FALSE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Catalent Pharma Solutions, LLC's FDA import refusal history?
Catalent Pharma Solutions, LLC (FEI: 1811396) has 52 FDA import refusal record(s) in our database, spanning from 11/28/2007 to 7/19/2017.
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. Catalent Pharma Solutions, LLC's FEI number is 1811396.
What types of violations has Catalent Pharma Solutions, LLC received?
Catalent Pharma Solutions, LLC 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 Catalent Pharma Solutions, LLC come from?
All FDA import refusal data for Catalent Pharma Solutions, LLC 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.