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Splash Mfg. Inc.

⚠️ Moderate Risk

FEI: 3003621796 • Valenzuela • PHILIPPINES

FEI

FEI Number

3003621796

📍

Location

Valenzuela

🇵🇭
🏢

Address

2 R. Jacinto St., , Valenzuela, , Philippines

Moderate Risk

FDA Import Risk Assessment

48.7
LowModerateHighCritical

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

Statistics

15
Total Refusals
4
Unique Violations
11/20/2003
Latest Refusal
6/30/2003
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
44.6×30%
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

© ImportRefusal.com Original Analysis

Violation Summary

11814×

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).

758×

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).

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
11/20/2003
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/20/2003
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/20/2003
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/20/2003
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/20/2003
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/20/2003
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/20/2003
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/20/2003
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/20/2003
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
11/20/2003
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
11/20/2003
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
11/20/2003
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
11/20/2003
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
6/30/2003
85HHDPAD, MENSTRUAL, UNSCENTED
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)
6/30/2003
63VDK02HYDROQUINONE (DEPIGMENTOR)
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Splash Mfg. Inc.'s FDA import refusal history?

Splash Mfg. Inc. (FEI: 3003621796) has 15 FDA import refusal record(s) in our database, spanning from 6/30/2003 to 11/20/2003.

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. Splash Mfg. Inc.'s FEI number is 3003621796.

What types of violations has Splash Mfg. Inc. received?

Splash Mfg. Inc. 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 Splash Mfg. Inc. come from?

All FDA import refusal data for Splash Mfg. Inc. 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.