Pekana Naturheilmittel GmbH
⚠️ High Risk
FEI: 3002037061 • Kislegg, Baden-Wurttemberg • GERMANY
FEI Number
3002037061
Location
Kislegg, Baden-Wurttemberg
Country
GERMANYAddress
Raiffeisenstr. 15, , Kislegg, Baden-Wurttemberg, Germany
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
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
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/26/2025 | 66XCL99HOMEOPATHIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/11/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/18/2023 | 65CDY99NUTRIENT/TONIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/30/2019 | 56KYK99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 3500RXLABEL | Division of West Coast Imports (DWCI) |
| 4/30/2019 | 56KYK99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 3500RXLABEL | Division of West Coast Imports (DWCI) |
| 4/8/2019 | 56KYK99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 4/8/2019 | 56KYK99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 4/8/2019 | 56KYK99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 4/8/2019 | 56KYK99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 4/8/2019 | 56KYK99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 4/8/2019 | 56KYK99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 4/8/2019 | 56KYK99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 4/8/2019 | 56KYK99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 4/8/2019 | 56KYK99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 4/8/2019 | 56KYK99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 4/8/2019 | 56KYK99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 4/8/2019 | 56KYK99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 1/2/2019 | 56KYK99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 1/2/2019 | 56KYK99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 1/2/2019 | 56KYK99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 1/2/2019 | 56KYK99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 9/26/2016 | 56KYK99MISCELLANEOUS ANTIBIOTICS, N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 8/14/2003 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pekana Naturheilmittel GmbH's FDA import refusal history?
Pekana Naturheilmittel GmbH (FEI: 3002037061) has 23 FDA import refusal record(s) in our database, spanning from 8/14/2003 to 8/26/2025.
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. Pekana Naturheilmittel GmbH's FEI number is 3002037061.
What types of violations has Pekana Naturheilmittel GmbH received?
Pekana Naturheilmittel GmbH has been cited for 5 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 Pekana Naturheilmittel GmbH come from?
All FDA import refusal data for Pekana Naturheilmittel GmbH 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.