Tejas, S.R.O.

⚠️ Moderate Risk

FEI: 3006506970 • Kokonin, Liberecky • CZECH REPUBLIC

FEI

FEI Number

3006506970

📍

Location

Kokonin, Liberecky

🇨🇿

Country

CZECH REPUBLIC

🏢

Address

Jahodova 4218, , Kokonin, Liberecky, Czech Republic

Moderate Risk

FDA Import Risk Assessment

46.7

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

12/20/2007

Latest Refusal

11/28/2007

Earliest Refusal

Score Breakdown

Violation Severity

58.3×40%

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

Violation Summary

11815×

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).

50814×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

Refusal History

Date	Product	Violations	Division
12/20/2007	91DJZDEVICES, BREATH TRAPPING, ALCOHOL	118NOT LISTED 508NO 510(K)	New York District Office (NYK-DO)
12/20/2007	91DJZDEVICES, BREATH TRAPPING, ALCOHOL	118NOT LISTED 508NO 510(K)	New York District Office (NYK-DO)
12/20/2007	91DJZDEVICES, BREATH TRAPPING, ALCOHOL	118NOT LISTED 508NO 510(K)	New York District Office (NYK-DO)
12/20/2007	91DJZDEVICES, BREATH TRAPPING, ALCOHOL	118NOT LISTED 508NO 510(K)	New York District Office (NYK-DO)
12/20/2007	91DJZDEVICES, BREATH TRAPPING, ALCOHOL	118NOT LISTED 508NO 510(K)	New York District Office (NYK-DO)
12/20/2007	91DJZDEVICES, BREATH TRAPPING, ALCOHOL	118NOT LISTED 508NO 510(K)	New York District Office (NYK-DO)
12/20/2007	91DJZDEVICES, BREATH TRAPPING, ALCOHOL	118NOT LISTED 508NO 510(K)	New York District Office (NYK-DO)
12/20/2007	91DJZDEVICES, BREATH TRAPPING, ALCOHOL	118NOT LISTED 508NO 510(K)	New York District Office (NYK-DO)
12/20/2007	91DJZDEVICES, BREATH TRAPPING, ALCOHOL	118NOT LISTED 508NO 510(K)	New York District Office (NYK-DO)
12/20/2007	91DJZDEVICES, BREATH TRAPPING, ALCOHOL	118NOT LISTED 508NO 510(K)	New York District Office (NYK-DO)
12/20/2007	91DJZDEVICES, BREATH TRAPPING, ALCOHOL	118NOT LISTED 508NO 510(K)	New York District Office (NYK-DO)
12/20/2007	91DJZDEVICES, BREATH TRAPPING, ALCOHOL	118NOT LISTED 508NO 510(K)	New York District Office (NYK-DO)
12/20/2007	91DJZDEVICES, BREATH TRAPPING, ALCOHOL	118NOT LISTED 508NO 510(K)	New York District Office (NYK-DO)
12/20/2007	91DJZDEVICES, BREATH TRAPPING, ALCOHOL	118NOT LISTED 508NO 510(K)	New York District Office (NYK-DO)
11/28/2007	91DJZDEVICES, BREATH TRAPPING, ALCOHOL	118NOT LISTED 333LACKS FIRM	New York District Office (NYK-DO)

Frequently Asked Questions

What is Tejas, S.R.O.'s FDA import refusal history?

Tejas, S.R.O. (FEI: 3006506970) has 15 FDA import refusal record(s) in our database, spanning from 11/28/2007 to 12/20/2007.

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. Tejas, S.R.O.'s FEI number is 3006506970.

What types of violations has Tejas, S.R.O. received?

Tejas, S.R.O. 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 Tejas, S.R.O. come from?

All FDA import refusal data for Tejas, S.R.O. 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.