Helios Homeopathic Pharmacy

⚠️ Moderate Risk

FEI: 3002739761 • Tunbridge Wells, Kent • UNITED KINGDOM

FEI

FEI Number

3002739761

📍

Location

Tunbridge Wells, Kent

🇬🇧

Country

UNITED KINGDOM

🏢

Address

97 Camden Road, , Tunbridge Wells, Kent, United Kingdom

Moderate Risk

FDA Import Risk Assessment

42.9

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/21/2012

Latest Refusal

12/6/2011

Earliest Refusal

Score Breakdown

Violation Severity

40.9×40%

Refusal Volume

55.2×30%

Recency

0.0×20%

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

Violation Summary

21829×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

47329×

LABELING

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

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).

Refusal History

Date	Product	Violations	Division
2/21/2012	54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	75UNAPPROVED	Cincinnati District Office (CIN-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54YDA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54YDA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)
12/6/2011	54FDA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	218LIST INGRE 473LABELING	Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Helios Homeopathic Pharmacy's FDA import refusal history?

Helios Homeopathic Pharmacy (FEI: 3002739761) has 30 FDA import refusal record(s) in our database, spanning from 12/6/2011 to 2/21/2012.

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. Helios Homeopathic Pharmacy's FEI number is 3002739761.

What types of violations has Helios Homeopathic Pharmacy received?

Helios Homeopathic Pharmacy 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 Helios Homeopathic Pharmacy come from?

All FDA import refusal data for Helios Homeopathic Pharmacy 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.