B.B. Pharma Co.,Ltd.
⚠️ Moderate Risk
FEI: 3006811280 • Prathumthani • THAILAND
FEI Number
3006811280
Location
Prathumthani
Country
THAILANDAddress
999 Thamasart Chaingrak Road, , Prathumthani, , Thailand
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
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
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 |
|---|---|---|---|
| 8/7/2012 | 54ECL99HERBALS & BOTANICAL TEAS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 6/12/2012 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/20/2009 | 54ECT99HERBALS & BOTANICAL TEAS, N.E.C. | 62NEEDS FCE | Los Angeles District Office (LOS-DO) |
| 3/27/2009 | 29YEE99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 2/24/2009 | 31KCE99TEA, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is B.B. Pharma Co.,Ltd.'s FDA import refusal history?
B.B. Pharma Co.,Ltd. (FEI: 3006811280) has 5 FDA import refusal record(s) in our database, spanning from 2/24/2009 to 8/7/2012.
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. B.B. Pharma Co.,Ltd.'s FEI number is 3006811280.
What types of violations has B.B. Pharma Co.,Ltd. received?
B.B. Pharma Co.,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 B.B. Pharma Co.,Ltd. come from?
All FDA import refusal data for B.B. Pharma 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.