Sp Gmbh & Co Kg

⚠️ Moderate Risk

FEI: 3009107828 • Pulheim, North Rhine-Westphalia • GERMANY

FEI

FEI Number

3009107828

📍

Location

Pulheim, North Rhine-Westphalia

🇩🇪

Country

GERMANY

🏢

Address

Carl-Friedrich-Gaus-Str. 11, , Pulheim, North Rhine-Westphalia, Germany

Moderate Risk

FDA Import Risk Assessment

41.4

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

3/30/2012

Latest Refusal

3/30/2012

Earliest Refusal

Score Breakdown

Violation Severity

44.4×40%

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

47116×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

4754×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

1181×

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).

4741×

COSMETLBLG

It appears the label does not bear the common or usual name of the cosmetic.

751×

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).

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

1971×

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).

Refusal History

Date	Product	Violations	Division
3/30/2012	53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG 475COSMETLBLG	New Orleans District Office (NOL-DO)
3/30/2012	53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG 475COSMETLBLG	New Orleans District Office (NOL-DO)
3/30/2012	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG 475COSMETLBLG	New Orleans District Office (NOL-DO)
3/30/2012	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG 475COSMETLBLG	New Orleans District Office (NOL-DO)
3/30/2012	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG 473LABELING 474COSMETLBLG	New Orleans District Office (NOL-DO)
3/30/2012	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG 75UNAPPROVED	New Orleans District Office (NOL-DO)
3/30/2012	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG	New Orleans District Office (NOL-DO)
3/30/2012	53CY99OTHER EYE MAKEUP PREPARATIONS, N.E.C.	471CSTIC LBLG	New Orleans District Office (NOL-DO)
3/30/2012	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG	New Orleans District Office (NOL-DO)
3/30/2012	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG	New Orleans District Office (NOL-DO)
3/30/2012	53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG	New Orleans District Office (NOL-DO)
3/30/2012	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG	New Orleans District Office (NOL-DO)
3/30/2012	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG	New Orleans District Office (NOL-DO)
3/30/2012	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG	New Orleans District Office (NOL-DO)
3/30/2012	53MD01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS)	197COSM COLOR 471CSTIC LBLG	New Orleans District Office (NOL-DO)
3/30/2012	53MD01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS)	118NOT LISTED 471CSTIC LBLG	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Sp Gmbh & Co Kg's FDA import refusal history?

Sp Gmbh & Co Kg (FEI: 3009107828) has 16 FDA import refusal record(s) in our database, spanning from 3/30/2012 to 3/30/2012.

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. Sp Gmbh & Co Kg's FEI number is 3009107828.

What types of violations has Sp Gmbh & Co Kg received?

Sp Gmbh & Co Kg has been cited for 7 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 Sp Gmbh & Co Kg come from?

All FDA import refusal data for Sp Gmbh & Co Kg 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.