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Antonio Puig Sa

⚠️ Moderate Risk

FEI: 1000156866 • Barcelona, Barcelona • SPAIN

FEI

FEI Number

1000156866

📍

Location

Barcelona, Barcelona

🇪🇸

Country

SPAIN
🏢

Address

Travessera de Gracia 9, , Barcelona, Barcelona, Spain

Moderate Risk

FDA Import Risk Assessment

32.9
LowModerateHighCritical

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

Statistics

15
Total Refusals
4
Unique Violations
6/14/2011
Latest Refusal
12/15/2003
Earliest Refusal

Score Breakdown

Violation Severity
43.8×40%
Refusal Volume
44.6×30%
Recency
0.0×20%
Frequency
20.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

47112×

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.

4739×

LABELING

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

752×

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).

4721×

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

DateProductViolationsDivision
6/14/2011
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Southwest Import District Office (SWI-DO)
6/14/2011
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Southwest Import District Office (SWI-DO)
6/14/2011
53JI02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
Southwest Import District Office (SWI-DO)
10/18/2006
66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
Florida District Office (FLA-DO)
10/18/2006
66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Florida District Office (FLA-DO)
7/29/2005
53DD02PERFUMES (FRAGRANCE PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)
12/15/2003
53LI03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
Florida District Office (FLA-DO)
12/15/2003
53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
Florida District Office (FLA-DO)
12/15/2003
53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
Florida District Office (FLA-DO)
12/15/2003
53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
Florida District Office (FLA-DO)
12/15/2003
53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
Florida District Office (FLA-DO)
12/15/2003
53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
Florida District Office (FLA-DO)
12/15/2003
53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
Florida District Office (FLA-DO)
12/15/2003
53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
Florida District Office (FLA-DO)
12/15/2003
53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Antonio Puig Sa's FDA import refusal history?

Antonio Puig Sa (FEI: 1000156866) has 15 FDA import refusal record(s) in our database, spanning from 12/15/2003 to 6/14/2011.

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. Antonio Puig Sa's FEI number is 1000156866.

What types of violations has Antonio Puig Sa received?

Antonio Puig Sa 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 Antonio Puig Sa come from?

All FDA import refusal data for Antonio Puig Sa 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.