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Anhui Anke Biotechnology Co., Ltd.

⚠️ High Risk

FEI: 2000009332 • Anhui, CN-34 • CHINA

FEI

FEI Number

2000009332

📍

Location

Anhui, CN-34

🇨🇳

Country

CHINA
🏢

Address

AnkeBio Building,, 669 Changjiang Road, West, Hefei, Anhui, CN-34, China

High Risk

FDA Import Risk Assessment

52.9
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

13
Total Refusals
2
Unique Violations
12/4/2006
Latest Refusal
10/18/2004
Earliest Refusal

Score Breakdown

Violation Severity
85.2×40%
Refusal Volume
42.5×30%
Recency
0.0×20%
Frequency
61.1×10%
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

7513×

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).

2712×

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

DateProductViolationsDivision
12/4/2006
64RCP18HUMAN GROWTH HORMONE (HORMONE)
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)
10/23/2004
64RCK99HORMONE N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
10/23/2004
64RCK99HORMONE N.E.C.
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)
10/23/2004
64RCK99HORMONE N.E.C.
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)
10/23/2004
64RCK99HORMONE N.E.C.
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)
10/23/2004
64RCK99HORMONE N.E.C.
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)
10/23/2004
64RCK99HORMONE N.E.C.
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)
10/23/2004
64RCK99HORMONE N.E.C.
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)
10/23/2004
64RCK99HORMONE N.E.C.
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)
10/18/2004
64RCK99HORMONE N.E.C.
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)
10/18/2004
64RCK99HORMONE N.E.C.
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)
10/18/2004
64RCK99HORMONE N.E.C.
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)
10/18/2004
64RCK99HORMONE N.E.C.
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Anhui Anke Biotechnology Co., Ltd.'s FDA import refusal history?

Anhui Anke Biotechnology Co., Ltd. (FEI: 2000009332) has 13 FDA import refusal record(s) in our database, spanning from 10/18/2004 to 12/4/2006.

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. Anhui Anke Biotechnology Co., Ltd.'s FEI number is 2000009332.

What types of violations has Anhui Anke Biotechnology Co., Ltd. received?

Anhui Anke Biotechnology Co., 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 Anhui Anke Biotechnology Co., Ltd. come from?

All FDA import refusal data for Anhui Anke Biotechnology 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.