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Rxhomeo Private Limited

⚠️ High Risk

FEI: 3005269310 • Hyderabad, Telangana • INDIA

FEI

FEI Number

3005269310

📍

Location

Hyderabad, Telangana

🇮🇳

Country

INDIA
🏢

Address

Indradhanush, Abids, 4-1-424 To 426 Bank Street, Hyderabad, Telangana, India

High Risk

FDA Import Risk Assessment

69.5
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

59
Total Refusals
7
Unique Violations
3/21/2023
Latest Refusal
10/10/2017
Earliest Refusal

Score Breakdown

Violation Severity
77.5×40%
Refusal Volume
65.9×30%
Recency
43.8×20%
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

© ImportRefusal.com Original Analysis

Violation Summary

2756×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

1182×

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).

751×

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).

28801×

RXCOMPOUND

the labeling fails to bear, at a minimum, the symbol "Rx only."

35001×

RXLABEL

The labeling fails to bear, at a minimum, the symbol "RX Only".

35601×

SUPPL GMP

The article appears to be a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.

Refusal History

DateProductViolationsDivision
3/21/2023
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
1/19/2023
54AYY99VITAMIN, N.E.C.
27DRUG GMPS
Division of Southeast Imports (DSEI)
1/19/2023
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
1/19/2023
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/21/2022
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/6/2022
66VDL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/6/2022
66VDL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/6/2022
66VDL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/6/2022
66VDL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/6/2022
66VDL99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/6/2022
66VDA99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/6/2022
66VDA99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/6/2022
66VDA99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/6/2022
66VDA99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/6/2022
66VDA99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/2/2022
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/2/2022
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/2/2022
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/2/2022
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/2/2022
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/2/2022
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/2/2022
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/2/2022
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/2/2022
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/2/2022
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/2/2022
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/2/2022
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/2/2022
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
8/31/2022
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
8/31/2022
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
8/29/2022
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
8/23/2022
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
8/23/2022
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
8/23/2022
55RP47SUCROSE (PHARMACEUTIC NECESSITY - TABLET EXCIPIENT)
27DRUG GMPS
Division of Southeast Imports (DSEI)
8/22/2022
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
7/27/2022
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
7/25/2022
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
7/11/2022
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
6/10/2022
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
6/10/2022
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
4/7/2022
54FYY07COMFREY (HERBAL & BOTANICALS, NOT TEAS)
27DRUG GMPS
Division of Southeast Imports (DSEI)
4/1/2022
60LBY99ANALGESIC, N.E.C.
27DRUG GMPS
Division of Southeast Imports (DSEI)
3/23/2022
60LBY99ANALGESIC, N.E.C.
27DRUG GMPS
Division of Southeast Imports (DSEI)
3/23/2022
60LBY99ANALGESIC, N.E.C.
27DRUG GMPS
Division of Southeast Imports (DSEI)
3/23/2022
60LBY99ANALGESIC, N.E.C.
27DRUG GMPS
Division of Southeast Imports (DSEI)
3/23/2022
60LBY99ANALGESIC, N.E.C.
27DRUG GMPS
Division of Southeast Imports (DSEI)
3/16/2022
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
3560SUPPL GMP
Division of Southeast Imports (DSEI)
3/16/2022
60LBY99ANALGESIC, N.E.C.
27DRUG GMPS
Division of Southeast Imports (DSEI)
3/16/2022
60LBY99ANALGESIC, N.E.C.
27DRUG GMPS
Division of Southeast Imports (DSEI)
3/14/2022
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
27DRUG GMPS
Division of Southeast Imports (DSEI)
2/28/2022
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
2/25/2022
61TAY99ANTI-EMETIC/NAUSEANT N.E.C.
27DRUG GMPS
Division of Southeast Imports (DSEI)
2/25/2022
61EAY99ANTI-ASTHMATIC, N.E.C.
27DRUG GMPS
Division of Southeast Imports (DSEI)
2/25/2022
60SAY99ANTACID, N.E.C.
27DRUG GMPS
Division of Southeast Imports (DSEI)
2/25/2022
60LAY99ANALGESIC, N.E.C.
27DRUG GMPS
Division of Southeast Imports (DSEI)
2/25/2022
61NAY99ANTI-DEPRESSANT N.E.C.
27DRUG GMPS
Division of Southeast Imports (DSEI)
2/25/2022
60LBY99ANALGESIC, N.E.C.
27DRUG GMPS
Division of Southeast Imports (DSEI)
10/10/2017
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
16DIRECTIONS
3500RXLABEL
Division of Southwest Imports (DSWI)
10/10/2017
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
16DIRECTIONS
2880RXCOMPOUND
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is Rxhomeo Private Limited's FDA import refusal history?

Rxhomeo Private Limited (FEI: 3005269310) has 59 FDA import refusal record(s) in our database, spanning from 10/10/2017 to 3/21/2023.

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. Rxhomeo Private Limited's FEI number is 3005269310.

What types of violations has Rxhomeo Private Limited received?

Rxhomeo Private Limited has been cited for 7 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 Rxhomeo Private Limited come from?

All FDA import refusal data for Rxhomeo 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.