Jnc Nutrachem Inc.

⚠️ Moderate Risk

FEI: 3003695552 • Ningbo • CHINA

FEI

FEI Number

3003695552

📍

Location

Ningbo

🇨🇳

Country

CHINA

🏢

Address

Ningbo Free Trade Zone Zhejiang Province, , Ningbo, , China

Moderate Risk

FDA Import Risk Assessment

38.7

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

11/16/2006

Latest Refusal

6/2/2004

Earliest Refusal

Score Breakdown

Violation Severity

64.6×40%

Refusal Volume

33.5×30%

Recency

0.0×20%

Frequency

28.5×10%

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

Violation Summary

1186×

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).

164×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

752×

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).

31001×

ANDRO

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to declare and/or contain androstenedione, a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

Refusal History

Date	Product	Violations	Division
11/16/2006	60KCS99ANABOLIC, N.E.C.	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
11/16/2006	60KCS99ANABOLIC, N.E.C.	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
9/1/2006	62FAR34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL)	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
1/5/2006	66SBZ40INOSITOL NIACINATE (VASODILATOR)	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
3/1/2005	54YBT99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	3100ANDRO	New York District Office (NYK-DO)
6/2/2004	66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
6/2/2004	66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)

Frequently Asked Questions

What is Jnc Nutrachem Inc.'s FDA import refusal history?

Jnc Nutrachem Inc. (FEI: 3003695552) has 7 FDA import refusal record(s) in our database, spanning from 6/2/2004 to 11/16/2006.

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. Jnc Nutrachem Inc.'s FEI number is 3003695552.

What types of violations has Jnc Nutrachem Inc. received?

Jnc Nutrachem Inc. has been cited for 4 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 Jnc Nutrachem Inc. come from?

All FDA import refusal data for Jnc Nutrachem Inc. 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.