Teh Seng Pharmaceutical Mfg. Co., Ltd. 3rd Plant
⚠️ Moderate Risk
FEI: 3003834002 • Tainan City • TAIWAN
FEI Number
3003834002
Location
Tainan City
Country
TAIWANAddress
63 Huangong Rd., Yongkang Dist., Tainan City, , Taiwan
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
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/30/2009 | 60LBJ99ANALGESIC, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/22/2006 | 60LAY99ANALGESIC, N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 4/18/2006 | 60LIY99ANALGESIC, N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 1/17/2002 | 79GEKGAUZE, NONABSORABLE, NON-MEDICATED (INTERNAL SPONGE) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Teh Seng Pharmaceutical Mfg. Co., Ltd. 3rd Plant's FDA import refusal history?
Teh Seng Pharmaceutical Mfg. Co., Ltd. 3rd Plant (FEI: 3003834002) has 4 FDA import refusal record(s) in our database, spanning from 1/17/2002 to 7/30/2009.
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. Teh Seng Pharmaceutical Mfg. Co., Ltd. 3rd Plant's FEI number is 3003834002.
What types of violations has Teh Seng Pharmaceutical Mfg. Co., Ltd. 3rd Plant received?
Teh Seng Pharmaceutical Mfg. Co., Ltd. 3rd Plant 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 Teh Seng Pharmaceutical Mfg. Co., Ltd. 3rd Plant come from?
All FDA import refusal data for Teh Seng Pharmaceutical Mfg. Co., Ltd. 3rd Plant 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.