Boai NKY Pharmaceuticals Ltd.
⚠️ Moderate Risk
FEI: 2000022086 • Jiaozuo, Henan • CHINA
FEI Number
2000022086
Location
Jiaozuo, Henan
Country
CHINAAddress
No. 1888 Wenhua Road, Boaixian, Jiaozuo, Henan, China
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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/24/2010 | 55RP46PREGELATINIZED STARCH (PHARMACEUTIC NECESSITY - TABLET EXCIPIENT) | 27DRUG GMPS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Boai NKY Pharmaceuticals Ltd.'s FDA import refusal history?
Boai NKY Pharmaceuticals Ltd. (FEI: 2000022086) has 1 FDA import refusal record(s) in our database, spanning from 11/24/2010 to 11/24/2010.
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. Boai NKY Pharmaceuticals Ltd.'s FEI number is 2000022086.
What types of violations has Boai NKY Pharmaceuticals Ltd. received?
Boai NKY Pharmaceuticals Ltd. has been cited for 1 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 Boai NKY Pharmaceuticals Ltd. come from?
All FDA import refusal data for Boai NKY Pharmaceuticals 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.