Procter & Gamble Manufacturing GmbH
⚠️ Moderate Risk
FEI: 3001903296 • Gros-Gerau, Hassia • GERMANY
FEI Number
3001903296
Location
Gros-Gerau, Hassia
Country
GERMANYAddress
Procter-Und-Gamble-Str. 1, , Gros-Gerau, Hassia, 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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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 |
|---|---|---|---|
| 7/14/2023 | 60LBL99ANALGESIC, N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/7/2023 | 65LBQ16HYDROXYPROPYL CELLULOSE (PROTECTANT) | Division of Southeast Imports (DSEI) | |
| 3/1/2007 | 60LDJ07CAMPHORATED OIL | Baltimore District Office (BLT-DO) | |
| 10/19/2006 | 60QBY56BENZOCAINE (ANESTHETIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 10/19/2006 | 60QBY56BENZOCAINE (ANESTHETIC) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Procter & Gamble Manufacturing GmbH's FDA import refusal history?
Procter & Gamble Manufacturing GmbH (FEI: 3001903296) has 5 FDA import refusal record(s) in our database, spanning from 10/19/2006 to 7/14/2023.
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. Procter & Gamble Manufacturing GmbH's FEI number is 3001903296.
What types of violations has Procter & Gamble Manufacturing GmbH received?
Procter & Gamble Manufacturing GmbH has been cited for 4 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 Procter & Gamble Manufacturing GmbH come from?
All FDA import refusal data for Procter & Gamble Manufacturing 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.