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RAMONA COSMACEUTICALS PRIVATE LIMITED

⚠️ Moderate Risk

FEI: 3006794691 • Pudupalaiyam, Tamil Nadu • INDIA

FEI

FEI Number

3006794691

📍

Location

Pudupalaiyam, Tamil Nadu

🇮🇳

Country

INDIA
🏢

Address

289 Railway Feeder Road, , Pudupalaiyam, Tamil Nadu, India

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
2/23/2011
Latest Refusal
2/23/2011
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

3352×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

752×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

1861×

INSANITARY

The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
2/23/2011
66VDR99MISCELLANEOUS PATENT MEDICINES, ETC.
335LACKS N/C
75UNAPPROVED
Southwest Import District Office (SWI-DO)
2/23/2011
66VDR99MISCELLANEOUS PATENT MEDICINES, ETC.
186INSANITARY
335LACKS N/C
75UNAPPROVED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is RAMONA COSMACEUTICALS PRIVATE LIMITED's FDA import refusal history?

RAMONA COSMACEUTICALS PRIVATE LIMITED (FEI: 3006794691) has 2 FDA import refusal record(s) in our database, spanning from 2/23/2011 to 2/23/2011.

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. RAMONA COSMACEUTICALS PRIVATE LIMITED's FEI number is 3006794691.

What types of violations has RAMONA COSMACEUTICALS PRIVATE LIMITED received?

RAMONA COSMACEUTICALS PRIVATE LIMITED 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 RAMONA COSMACEUTICALS PRIVATE LIMITED come from?

All FDA import refusal data for RAMONA COSMACEUTICALS PRIVATE LIMITED 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.