SO SHAPE SAS

⚠️ Moderate Risk

FEI: 3017429512 • Paris, Paris • FRANCE

FEI

FEI Number

3017429512

📍

Location

Paris, Paris

🇫🇷

Country

FRANCE

🏢

Address

25 Rue De Ponthieu, , Paris, Paris, France

Moderate Risk

FDA Import Risk Assessment

49.7

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

11/12/2020

Latest Refusal

11/12/2020

Earliest Refusal

Score Breakdown

Violation Severity

65.0×40%

Refusal Volume

45.6×30%

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

21816×

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.

23816×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

330016×

ALLERGEN

the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).

48216×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

Refusal History

Date	Product	Violations	Division
11/12/2020	41EDY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	218LIST INGRE 238UNSAFE ADD 3300ALLERGEN 482NUTRIT LBL	Division of Southeast Imports (DSEI)
11/12/2020	41EDY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	218LIST INGRE 238UNSAFE ADD 3300ALLERGEN 482NUTRIT LBL	Division of Southeast Imports (DSEI)
11/12/2020	41EDY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	218LIST INGRE 238UNSAFE ADD 3300ALLERGEN 482NUTRIT LBL	Division of Southeast Imports (DSEI)
11/12/2020	41EDY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	218LIST INGRE 238UNSAFE ADD 3300ALLERGEN 482NUTRIT LBL	Division of Southeast Imports (DSEI)
11/12/2020	41EDY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	218LIST INGRE 238UNSAFE ADD 3300ALLERGEN 482NUTRIT LBL	Division of Southeast Imports (DSEI)
11/12/2020	41EDY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	218LIST INGRE 238UNSAFE ADD 3300ALLERGEN 482NUTRIT LBL	Division of Southeast Imports (DSEI)
11/12/2020	41EDY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	218LIST INGRE 238UNSAFE ADD 3300ALLERGEN 482NUTRIT LBL	Division of Southeast Imports (DSEI)
11/12/2020	41EDY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	218LIST INGRE 238UNSAFE ADD 3300ALLERGEN 482NUTRIT LBL	Division of Southeast Imports (DSEI)
11/12/2020	41EDY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	218LIST INGRE 238UNSAFE ADD 3300ALLERGEN 482NUTRIT LBL	Division of Southeast Imports (DSEI)
11/12/2020	41EDY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	218LIST INGRE 238UNSAFE ADD 3300ALLERGEN 482NUTRIT LBL	Division of Southeast Imports (DSEI)
11/12/2020	41EDY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	218LIST INGRE 238UNSAFE ADD 3300ALLERGEN 482NUTRIT LBL	Division of Southeast Imports (DSEI)
11/12/2020	41EDY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	218LIST INGRE 238UNSAFE ADD 3300ALLERGEN 482NUTRIT LBL	Division of Southeast Imports (DSEI)
11/12/2020	41EDY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	218LIST INGRE 238UNSAFE ADD 3300ALLERGEN 482NUTRIT LBL	Division of Southeast Imports (DSEI)
11/12/2020	41EDY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	218LIST INGRE 238UNSAFE ADD 3300ALLERGEN 482NUTRIT LBL	Division of Southeast Imports (DSEI)
11/12/2020	41EDY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	218LIST INGRE 238UNSAFE ADD 3300ALLERGEN 482NUTRIT LBL	Division of Southeast Imports (DSEI)
11/12/2020	41EDY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE)	218LIST INGRE 238UNSAFE ADD 3300ALLERGEN 482NUTRIT LBL	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SO SHAPE SAS's FDA import refusal history?

SO SHAPE SAS (FEI: 3017429512) has 16 FDA import refusal record(s) in our database, spanning from 11/12/2020 to 11/12/2020.

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. SO SHAPE SAS's FEI number is 3017429512.

What types of violations has SO SHAPE SAS received?

SO SHAPE SAS 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 SO SHAPE SAS come from?

All FDA import refusal data for SO SHAPE SAS 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.