Micro Engineering Company

⚠️ Moderate Risk

FEI: 1000128281 • Sialkot • PAKISTAN

FEI

FEI Number

1000128281

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN

🏢

Address

PO Box No 456, Muzaffar Pur Ugoki Road, Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

30.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

10/19/2009

Latest Refusal

10/25/2002

Earliest Refusal

Score Breakdown

Violation Severity

45.5×40%

Refusal Volume

37.0×30%

Recency

0.0×20%

Frequency

12.9×10%

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).

3414×

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).

4801×

STAINSTEEL

The article appears to be a device whose quality falls below that which it purports or is represented to possess, in that instrument is represented as stainless steel but does not meet requirements for such steel for surgical instruments.

Refusal History

Date	Product	Violations	Division
10/19/2009	77KAEFORCEPS, ENT	341REGISTERED	Chicago District Office (CHI-DO)
10/19/2009	84GWXFORK, TUNING	341REGISTERED	Chicago District Office (CHI-DO)
10/19/2009	77KCPSYRINGE, ENT	341REGISTERED	Chicago District Office (CHI-DO)
10/19/2009	79KDCINSTRUMENT, SURGICAL, DISPOSABLE	118NOT LISTED 341REGISTERED	Chicago District Office (CHI-DO)
9/28/2004	73CALLARYNGOSCOPE, NON-RIGID	118NOT LISTED	Chicago District Office (CHI-DO)
4/5/2004	76EHYTRAY, IMPRESSION, PREFORMED	118NOT LISTED	Chicago District Office (CHI-DO)
11/17/2003	76EAXMIRROR, MOUTH	118NOT LISTED	Chicago District Office (CHI-DO)
5/1/2003	76EICSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING	118NOT LISTED	Chicago District Office (CHI-DO)
10/25/2002	85HDFSPECULUM, VAGINAL, METAL	118NOT LISTED 480STAINSTEEL	Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Micro Engineering Company's FDA import refusal history?

Micro Engineering Company (FEI: 1000128281) has 9 FDA import refusal record(s) in our database, spanning from 10/25/2002 to 10/19/2009.

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. Micro Engineering Company's FEI number is 1000128281.

What types of violations has Micro Engineering Company received?

Micro Engineering Company 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 Micro Engineering Company come from?

All FDA import refusal data for Micro Engineering Company 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.