ALL PRO CORPORATION

⚠️ Moderate Risk

FEI: 3007028791 • Qingdao, Shandong • CHINA

FEI

FEI Number

3007028791

📍

Location

Qingdao, Shandong

🇨🇳

Country

CHINA

🏢

Address

Room 212, NO 592 Tonghelu, Qingdao, Shandong, China

Moderate Risk

FDA Import Risk Assessment

39.2

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

11/4/2016

Latest Refusal

9/30/2011

Earliest Refusal

Score Breakdown

Violation Severity

44.6×40%

Refusal Volume

53.6×30%

Recency

0.0×20%

Frequency

52.9×10%

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

34117×

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).

11810×

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).

5087×

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.

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

Date	Product	Violations	Division
11/4/2016	79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
2/25/2015	79FRODRESSING, WOUND, DRUG	508NO 510(K)	Los Angeles District Office (LOS-DO)
2/25/2015	79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
2/25/2015	79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
2/25/2015	79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
2/25/2015	79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
2/25/2015	80LYZGLOVE, PATIENT EXAMINATION, VINYL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
2/25/2015	79GAXTOURNIQUET, NONPNEUMATIC	341REGISTERED	Los Angeles District Office (LOS-DO)
2/25/2015	89IMDPACK, HOT OR COLD, DISPOSABLE	341REGISTERED	Los Angeles District Office (LOS-DO)
2/25/2015	73KGBMASK, OXYGEN, NON-REBREATHING	341REGISTERED	Los Angeles District Office (LOS-DO)
2/25/2015	80KGXTAPE AND BANDAGE, ADHESIVE	341REGISTERED	Los Angeles District Office (LOS-DO)
2/25/2015	80FQMBANDAGE, ELASTIC	341REGISTERED	Los Angeles District Office (LOS-DO)
2/25/2015	80FQMBANDAGE, ELASTIC	341REGISTERED	Los Angeles District Office (LOS-DO)
2/25/2015	80FQMBANDAGE, ELASTIC	341REGISTERED	Los Angeles District Office (LOS-DO)
2/25/2015	80FQMBANDAGE, ELASTIC	341REGISTERED	Los Angeles District Office (LOS-DO)
2/25/2015	79FRODRESSING, WOUND, DRUG	341REGISTERED	Los Angeles District Office (LOS-DO)
2/25/2015	80FQMBANDAGE, ELASTIC	341REGISTERED	Los Angeles District Office (LOS-DO)
2/25/2015	66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED	Los Angeles District Office (LOS-DO)
2/25/2015	60SAY99ANTACID, N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
2/25/2015	61HAY99ANTI-BACTERIAL, N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
2/25/2015	62GAA41IBUPROFEN (ANTI-INFLAMMATORY)	118NOT LISTED	Los Angeles District Office (LOS-DO)
2/25/2015	62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL)	118NOT LISTED	Los Angeles District Office (LOS-DO)
2/25/2015	55QY41BENZALKONIUM CHLORIDE (PHARMACEUTIC NECESSITY - PRESERVATIVE)	118NOT LISTED	Los Angeles District Office (LOS-DO)
2/25/2015	60QBK56BENZOCAINE (ANESTHETIC)	118NOT LISTED	Los Angeles District Office (LOS-DO)
1/24/2012	76NXZKIT, DENTAL HYGIENE	341REGISTERED	New York District Office (NYK-DO)
1/24/2012	76EAPUNIT, X-RAY, INTRAORAL	118NOT LISTED 341REGISTERED 476NO REGISTR	New York District Office (NYK-DO)
9/30/2011	80KZHINTRODUCER, SYRINGE NEEDLE	118NOT LISTED	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is ALL PRO CORPORATION's FDA import refusal history?

ALL PRO CORPORATION (FEI: 3007028791) has 27 FDA import refusal record(s) in our database, spanning from 9/30/2011 to 11/4/2016.

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. ALL PRO CORPORATION's FEI number is 3007028791.

What types of violations has ALL PRO CORPORATION received?

ALL PRO CORPORATION has been cited for 4 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 ALL PRO CORPORATION come from?

All FDA import refusal data for ALL PRO CORPORATION 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.