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GERMANY

GERMANY

FDA import refusal data for products from GERMANY

2827
Total Firms
11,113
Total Refusals
12/31/2025
Latest Refusal

Common Violations

3589

NOT LISTED

2267

UNAPPROVED

1651

REGISTERED

1412

FRNMFGREG

1280

NO 510(K)

673

NO ENGLISH

599

NUTRIT LBL

543

COSM COLOR

422

DIRECTIONS

10471
417

CSTIC LBLG

Top Firms

#Firm NameRiskRefusals
1
Voco GmbH

Cuxhaven

Risk: 69.4295
2Risk: 81.2246
3Risk: 80.8213
4Risk: 65.6191
5Risk: 59.7174
6Risk: 82.0172
7Risk: 81.6167
8Risk: 53.5164
9
Hipp GmbH & CO Vertrieb KG

Pfaffenhofen A.d.ilm

Risk: 67.1117
10
Admedes GmbH

Pforzheim

Risk: 71.1113
11Risk: 65.9103
12Risk: 76.1101
13
M Kappus Gmbh & Co

Offenbach Am Main

Risk: 54.3100
14Risk: 73.091
15
Sinoropa

Muriel

Risk: 49.485
16Risk: 64.277
17Risk: 74.168
18Risk: 42.466
19Risk: 53.765
20
Ciba Vision GmbH

Groswallstadt

Risk: 68.263

Frequently Asked Questions

How many FDA import refusals are from GERMANY?

According to FDA records, there have been 11,113 import refusals for products originating from GERMANY, involving 2827 firms.

What products from GERMANY are commonly refused by the FDA?

Products from GERMANY may be refused for various reasons including adulteration, misbranding, lack of proper registration, or failure to meet U.S. safety standards. The specific products vary by firm and time period. View the common violations section on this page for more details.

Does an import refusal mean products from GERMANY are unsafe?

Not necessarily. An import refusal indicates a specific shipment appeared to violate FDA requirements at the time of inspection. Many GERMANY firms successfully import products that meet all FDA requirements. Import refusals help identify and prevent non-compliant products from entering the U.S. market.

How current is the FDA import refusal data for GERMANY?

Our database includes FDA import refusals for GERMANY through 12/31/2025. Data is sourced from the FDA Data Dashboard and updated monthly.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.