Shree Umiya Surgical

⚠️ Moderate Risk

FEI: 3008939517 • Ahmedabad • INDIA

FEI

FEI Number

3008939517

📍

Location

Ahmedabad

🇮🇳

Country

INDIA

🏢

Address

Unknown Street, , Ahmedabad, , India

Moderate Risk

FDA Import Risk Assessment

42.7

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/4/2012

Latest Refusal

6/4/2012

Earliest Refusal

Score Breakdown

Violation Severity

40.0×40%

Refusal Volume

55.8×30%

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

Violation Summary

11831×

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).

34131×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

Date	Product	Violations	Division
6/4/2012	80NPDSURGEON'S GLOVES, POWDER FREE	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	73BYGMASK, OXYGEN	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	78EXBCOLLECTOR, OSTOMY	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	78FPDTUBE, FEEDING	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	78FPDTUBE, FEEDING	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	78KGCTUBE, GASTRO-ENTEROSTOMY	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	78KGCTUBE, GASTRO-ENTEROSTOMY	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	78KGCTUBE, GASTRO-ENTEROSTOMY	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	75OIEURINE COLLECTION KIT (EXCLUDES HIV TESTING)	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	73BYGMASK, OXYGEN	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	73BYGMASK, OXYGEN	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	73BYGMASK, OXYGEN	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	73LNZCHANGER, TUBE, ENDOTRACHEAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	79FXXMASK, SURGICAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	79FXXMASK, SURGICAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	80GCXAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	80GCXAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	73JAYSUPPORT, BREATHING TUBE	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	73JAYSUPPORT, BREATHING TUBE	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	73JAYSUPPORT, BREATHING TUBE	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	73JAYSUPPORT, BREATHING TUBE	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	79GBACATHETER, BALLOON TYPE	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	79GBACATHETER, BALLOON TYPE	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	85HFLDRAIN, CERVICAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)
6/4/2012	73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL	118NOT LISTED 341REGISTERED	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Shree Umiya Surgical's FDA import refusal history?

Shree Umiya Surgical (FEI: 3008939517) has 31 FDA import refusal record(s) in our database, spanning from 6/4/2012 to 6/4/2012.

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. Shree Umiya Surgical's FEI number is 3008939517.

What types of violations has Shree Umiya Surgical received?

Shree Umiya Surgical 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 Shree Umiya Surgical come from?

All FDA import refusal data for Shree Umiya Surgical 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.