CRITICARE SURGICALS & LABORATORY SUPPLIES

⚠️ Moderate Risk

FEI: 3010256582 • Shakarpur, Delhi • INDIA

FEI

FEI Number

3010256582

📍

Location

Shakarpur, Delhi

🇮🇳

Country

INDIA

🏢

Address

Ug-158, Lg 17 Vikas Marg, , Shakarpur, Delhi, India

Moderate Risk

FDA Import Risk Assessment

45.5

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

8/26/2013

Latest Refusal

8/26/2013

Earliest Refusal

Score Breakdown

Violation Severity

50.0×40%

Refusal Volume

51.8×30%

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

34124×

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).

50824×

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.

Refusal History

Date	Product	Violations	Division
8/26/2013	87HWCSCREW, FIXATION, BONE	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87HWCSCREW, FIXATION, BONE	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87HWCSCREW, FIXATION, BONE	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87HWCSCREW, FIXATION, BONE	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87HWCSCREW, FIXATION, BONE	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87HWCSCREW, FIXATION, BONE	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87HWCSCREW, FIXATION, BONE	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87HWCSCREW, FIXATION, BONE	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87HWCSCREW, FIXATION, BONE	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87HWCSCREW, FIXATION, BONE	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87HWCSCREW, FIXATION, BONE	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87HWCSCREW, FIXATION, BONE	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87HWCSCREW, FIXATION, BONE	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87HWCSCREW, FIXATION, BONE	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87HWCSCREW, FIXATION, BONE	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87HWCSCREW, FIXATION, BONE	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87KWLPROSTHESIS, HIP, HEMI-, FEMORAL, METAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87KWLPROSTHESIS, HIP, HEMI-, FEMORAL, METAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87KWLPROSTHESIS, HIP, HEMI-, FEMORAL, METAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87KWLPROSTHESIS, HIP, HEMI-, FEMORAL, METAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87KWLPROSTHESIS, HIP, HEMI-, FEMORAL, METAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87KWLPROSTHESIS, HIP, HEMI-, FEMORAL, METAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87KWLPROSTHESIS, HIP, HEMI-, FEMORAL, METAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
8/26/2013	87KWLPROSTHESIS, HIP, HEMI-, FEMORAL, METAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is CRITICARE SURGICALS & LABORATORY SUPPLIES's FDA import refusal history?

CRITICARE SURGICALS & LABORATORY SUPPLIES (FEI: 3010256582) has 24 FDA import refusal record(s) in our database, spanning from 8/26/2013 to 8/26/2013.

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. CRITICARE SURGICALS & LABORATORY SUPPLIES's FEI number is 3010256582.

What types of violations has CRITICARE SURGICALS & LABORATORY SUPPLIES received?

CRITICARE SURGICALS & LABORATORY SUPPLIES 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 CRITICARE SURGICALS & LABORATORY SUPPLIES come from?

All FDA import refusal data for CRITICARE SURGICALS & LABORATORY SUPPLIES 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.