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Port Jervis Laboratories, Inc.

⚠️ Moderate Risk

FEI: 1317131 • Port Jervis, NY • UNITED STATES

FEI

FEI Number

1317131

📍

Location

Port Jervis, NY

🇺🇸
🏢

Address

20 W King St, , Port Jervis, NY, United States

Moderate Risk

FDA Import Risk Assessment

27.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
10/7/2013
Latest Refusal
10/7/2013
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

4714×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

4734×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
10/7/2013
53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
New York District Office (NYK-DO)
10/7/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
New York District Office (NYK-DO)
10/7/2013
53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
New York District Office (NYK-DO)
10/7/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
New York District Office (NYK-DO)

Frequently Asked Questions

What is Port Jervis Laboratories, Inc.'s FDA import refusal history?

Port Jervis Laboratories, Inc. (FEI: 1317131) has 4 FDA import refusal record(s) in our database, spanning from 10/7/2013 to 10/7/2013.

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. Port Jervis Laboratories, Inc.'s FEI number is 1317131.

What types of violations has Port Jervis Laboratories, Inc. received?

Port Jervis Laboratories, Inc. 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 Port Jervis Laboratories, Inc. come from?

All FDA import refusal data for Port Jervis Laboratories, Inc. 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.