Shenton Pharmacy Pte.Ltd.
⚠️ Moderate Risk
FEI: 1000323793 • Shenton House, Singapore • SINGAPORE
FEI Number
1000323793
Location
Shenton House, Singapore
Country
SINGAPOREAddress
3 Shenton Way #02-09, Shenton House, Shenton House, Singapore, Singapore
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).
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 |
|---|---|---|---|
| 8/19/2004 | 60QAJ06HYDROXYDINE SODIUM SUCCINATE (ANESTHETIC) | New York District Office (NYK-DO) | |
| 8/19/2004 | 56BCB03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | New York District Office (NYK-DO) | |
| 8/19/2004 | 56BCL03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | New York District Office (NYK-DO) | |
| 8/19/2004 | 61XAB08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 8/19/2004 | 61XAB08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 8/19/2004 | 56BCL03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | New York District Office (NYK-DO) | |
| 8/19/2004 | 60QAJ67LIDOCAINE (ANESTHETIC) | New York District Office (NYK-DO) | |
| 8/19/2004 | 62VBJ18ACYCLOVIR (ANTI-VIRAL) | New York District Office (NYK-DO) | |
| 8/19/2004 | 56BCL03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Shenton Pharmacy Pte.Ltd.'s FDA import refusal history?
Shenton Pharmacy Pte.Ltd. (FEI: 1000323793) has 9 FDA import refusal record(s) in our database, spanning from 8/19/2004 to 8/19/2004.
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. Shenton Pharmacy Pte.Ltd.'s FEI number is 1000323793.
What types of violations has Shenton Pharmacy Pte.Ltd. received?
Shenton Pharmacy Pte.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 Shenton Pharmacy Pte.Ltd. come from?
All FDA import refusal data for Shenton Pharmacy Pte.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.