Bio Fresh Ltd.
⚠️ Moderate Risk
FEI: 3009135537 • Plovdiv, Plovdiv • BULGARIA
FEI Number
3009135537
Location
Plovdiv, Plovdiv
Country
BULGARIAAddress
Ul. Polk Sava Mutkurov 36, , Plovdiv, Plovdiv, Bulgaria
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
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 53JY99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 4/17/2014 | 53CD04EYE LOTION (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 4/17/2014 | 53DY01COLOGNES AND TOILET WATERS (FRAGRANCE PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 4/17/2014 | 53DY01COLOGNES AND TOILET WATERS (FRAGRANCE PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 4/17/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 4/17/2014 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 4/17/2014 | 53LY06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 4/17/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 4/17/2014 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 4/17/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 4/17/2014 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 4/17/2014 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 4/17/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 4/17/2014 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 4/17/2014 | 53EC06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | New England District Office (NWE-DO) |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) | |
| 4/17/2014 | 56YYY99ANTIBIOTIC N.E.C. | New England District Office (NWE-DO) |
Frequently Asked Questions
What is Bio Fresh Ltd.'s FDA import refusal history?
Bio Fresh Ltd. (FEI: 3009135537) has 45 FDA import refusal record(s) in our database, spanning from 4/17/2014 to 4/17/2014.
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. Bio Fresh Ltd.'s FEI number is 3009135537.
What types of violations has Bio Fresh Ltd. received?
Bio Fresh Ltd. 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 Bio Fresh Ltd. come from?
All FDA import refusal data for Bio Fresh 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.