Yunnan Crystal Natural Pharmaceutical Co.
⚠️ Moderate Risk
FEI: 3008183135 • Kunming, Yunnan • CHINA
FEI Number
3008183135
Location
Kunming, Yunnan
Country
CHINAAddress
Jin Tai Da F # 9 Sha, 48 Dongfeng East Rd, Kunming, Yunnan, 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
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(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.
Refusal History
Frequently Asked Questions
What is Yunnan Crystal Natural Pharmaceutical Co.'s FDA import refusal history?
Yunnan Crystal Natural Pharmaceutical Co. (FEI: 3008183135) has 2 FDA import refusal record(s) in our database, spanning from 1/18/2006 to 4/17/2009.
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. Yunnan Crystal Natural Pharmaceutical Co.'s FEI number is 3008183135.
What types of violations has Yunnan Crystal Natural Pharmaceutical Co. received?
Yunnan Crystal Natural Pharmaceutical Co. has been cited for 3 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 Yunnan Crystal Natural Pharmaceutical Co. come from?
All FDA import refusal data for Yunnan Crystal Natural Pharmaceutical Co. 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.