Johnny Mak Spa

⚠️ Moderate Risk

FEI: 3002423558 • Torre Del Greco, Naples • ITALY

FEI

FEI Number

3002423558

📍

Location

Torre Del Greco, Naples

🇮🇹

Country

ITALY

🏢

Address

Via Nazionale 429/431, , Torre Del Greco, Naples, Italy

Moderate Risk

FDA Import Risk Assessment

44.2

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

8/25/2004

Latest Refusal

6/21/2002

Earliest Refusal

Score Breakdown

Violation Severity

77.5×40%

Refusal Volume

33.5×30%

Recency

0.0×20%

Frequency

32.1×10%

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

836×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

625×

NEEDS FCE

It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).

1561×

NO PERMIT

The article of milk or cream is not accompanied by a valid import milk permit, as required by the Federal Import Milk Act (21 U.S.C. 141-149).

Refusal History

Date	Product	Violations	Division
8/25/2004	25YGT99VEGETABLE & VEGETABLE PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
8/25/2004	24FGT08PEPPER, HOT, N.E.C. (FRUIT USED AS VEGETABLE)	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/10/2004	09CYO95IMPORT MILK ACT	156NO PERMIT	New York District Office (NYK-DO)
11/1/2003	23ECT06FILBERT, HAZELNUT, SPREAD	83NO PROCESS	New York District Office (NYK-DO)
6/21/2002	24AGY99BEANS, CORN, AND PEA, N.E.C. (VEGETABLE)	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
6/21/2002	24FCN99FRUITS USED AS VEGETABLES, N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
6/21/2002	24EEY07KIDNEY BEAN, BEAN AND PEA SPROUTS	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)

Frequently Asked Questions

What is Johnny Mak Spa's FDA import refusal history?

Johnny Mak Spa (FEI: 3002423558) has 7 FDA import refusal record(s) in our database, spanning from 6/21/2002 to 8/25/2004.

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. Johnny Mak Spa's FEI number is 3002423558.

What types of violations has Johnny Mak Spa received?

Johnny Mak Spa 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 Johnny Mak Spa come from?

All FDA import refusal data for Johnny Mak Spa 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.