Bioprogramme Co. Ltd.
⚠️ High Risk
FEI: 3004251068 • Dobroslavtsi, Sofia • BULGARIA
FEI Number
3004251068
Location
Dobroslavtsi, Sofia
Country
BULGARIAAddress
Ul.Dobroslavsko Shose 1247, , Dobroslavtsi, Sofia, Bulgaria
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).
UNSFDIETLB
The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/31/2013 | 54FBT07COMFREY (HERBAL & BOTANICALS, NOT TEAS) | 2460UNSFDIETLB | New York District Office (NYK-DO) |
| 10/31/2013 | 54FBT07COMFREY (HERBAL & BOTANICALS, NOT TEAS) | 2460UNSFDIETLB | New York District Office (NYK-DO) |
| 10/31/2013 | 54FBT07COMFREY (HERBAL & BOTANICALS, NOT TEAS) | 2460UNSFDIETLB | New York District Office (NYK-DO) |
| 7/27/2012 | 54EBT99HERBALS & BOTANICAL TEAS, N.E.C. | 2460UNSFDIETLB | Division of Northeast Imports (DNEI) |
| 6/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 6/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 6/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 6/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 6/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 6/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 6/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 6/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 6/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 6/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 6/26/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Bioprogramme Co. Ltd.'s FDA import refusal history?
Bioprogramme Co. Ltd. (FEI: 3004251068) has 15 FDA import refusal record(s) in our database, spanning from 6/26/2012 to 10/31/2013.
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. Bioprogramme Co. Ltd.'s FEI number is 3004251068.
What types of violations has Bioprogramme Co. Ltd. received?
Bioprogramme Co. Ltd. has been cited for 2 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 Bioprogramme Co. Ltd. come from?
All FDA import refusal data for Bioprogramme Co. Ltd. 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.