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Shastha Keytech Pvt Ltd

⚠️ High Risk

FEI: 3004425183 • Chennai, Tamil Nadu • INDIA

FEI

FEI Number

3004425183

📍

Location

Chennai, Tamil Nadu

🇮🇳

Country

INDIA
🏢

Address

Cenotaph Road, , Chennai, Tamil Nadu, India

High Risk

FDA Import Risk Assessment

54.6
LowModerateHighCritical

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

Statistics

15
Total Refusals
8
Unique Violations
7/7/2005
Latest Refusal
9/20/2004
Earliest Refusal

Score Breakdown

Violation Severity
78.0×40%
Refusal Volume
44.6×30%
Recency
0.0×20%
Frequency
100.0×10%
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

119×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

833×

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.

623×

NEEDS FCE

It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).

3211×

LACKS N/C

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

2181×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

641×

YELLOW #5

The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.

2491×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

Refusal History

DateProductViolationsDivision
7/7/2005
37BEF99MULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS, N.E.C.
249FILTHY
San Francisco District Office (SAN-DO)
4/5/2005
07AGT99BAKED SNACK FOOD, N.E.C.
64YELLOW #5
San Francisco District Office (SAN-DO)
4/5/2005
07AGT99BAKED SNACK FOOD, N.E.C.
11UNSAFE COL
San Francisco District Office (SAN-DO)
4/5/2005
07AGT99BAKED SNACK FOOD, N.E.C.
11UNSAFE COL
San Francisco District Office (SAN-DO)
4/5/2005
07AGT99BAKED SNACK FOOD, N.E.C.
11UNSAFE COL
San Francisco District Office (SAN-DO)
4/5/2005
07AGT99BAKED SNACK FOOD, N.E.C.
11UNSAFE COL
San Francisco District Office (SAN-DO)
4/5/2005
07AGT99BAKED SNACK FOOD, N.E.C.
11UNSAFE COL
San Francisco District Office (SAN-DO)
4/5/2005
07AGT99BAKED SNACK FOOD, N.E.C.
11UNSAFE COL
San Francisco District Office (SAN-DO)
4/5/2005
07AGT99BAKED SNACK FOOD, N.E.C.
11UNSAFE COL
San Francisco District Office (SAN-DO)
4/5/2005
07AGT99BAKED SNACK FOOD, N.E.C.
11UNSAFE COL
San Francisco District Office (SAN-DO)
4/5/2005
07AGT99BAKED SNACK FOOD, N.E.C.
11UNSAFE COL
San Francisco District Office (SAN-DO)
10/4/2004
21VCT99SUTROPICAL AND TROPICAL FRUIT, JUICE, MILK, CREME, DRINK OR NECTAR, N.E.C.
218LIST INGRE
321LACKS N/C
482NUTRIT LBL
San Francisco District Office (SAN-DO)
9/20/2004
33BEE99HARD CANDY WITH COCONUT, N.E.C. (WITHOUT CHOCOLATE)
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)
9/20/2004
33BEE99HARD CANDY WITH COCONUT, N.E.C. (WITHOUT CHOCOLATE)
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)
9/20/2004
33BEE99HARD CANDY WITH COCONUT, N.E.C. (WITHOUT CHOCOLATE)
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Shastha Keytech Pvt Ltd's FDA import refusal history?

Shastha Keytech Pvt Ltd (FEI: 3004425183) has 15 FDA import refusal record(s) in our database, spanning from 9/20/2004 to 7/7/2005.

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. Shastha Keytech Pvt Ltd's FEI number is 3004425183.

What types of violations has Shastha Keytech Pvt Ltd received?

Shastha Keytech Pvt Ltd has been cited for 8 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 Shastha Keytech Pvt Ltd come from?

All FDA import refusal data for Shastha Keytech Pvt 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.