Heinrich Mack Nachf
⚠️ Moderate Risk
FEI: 10607 • Illertissen • GERMANY
FEI Number
10607
Location
Illertissen
Country
GERMANYAddress
Heinrich Mack Strasse, PO 20 64, Illertissen, , Germany
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/27/2005 | 64RCA19SERMORELIN ACETATE (HORMONE) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 9/18/2005 | 66NCB05ZIPRASIDONE HCI (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/23/2001 | 62ODB03PERINDOPRIL ERBUMINE (ANTI-HYPERTENSIVE - PART II) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Heinrich Mack Nachf's FDA import refusal history?
Heinrich Mack Nachf (FEI: 10607) has 3 FDA import refusal record(s) in our database, spanning from 10/23/2001 to 9/27/2005.
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. Heinrich Mack Nachf's FEI number is 10607.
What types of violations has Heinrich Mack Nachf received?
Heinrich Mack Nachf 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 Heinrich Mack Nachf come from?
All FDA import refusal data for Heinrich Mack Nachf 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.