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Gerden Pharmaceutical Laboratori

⚠️ Moderate Risk

FEI: 3005187766 • Cal City • PHILIPPINES

FEI

FEI Number

3005187766

📍

Location

Cal City

🇵🇭
🏢

Address

9818 Tirc Furniture City, , Cal City, , 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

11
Total Refusals
2
Unique Violations
11/22/2005
Latest Refusal
11/14/2005
Earliest Refusal

Score Breakdown

Violation Severity
66.8×40%
Refusal Volume
40.0×30%
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

11811×

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).

Refusal History

DateProductViolationsDivision
11/22/2005
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
San Francisco District Office (SAN-DO)
11/22/2005
53BY99OTHER BATH PREPARATIONS, N.E.C.
118NOT LISTED
San Francisco District Office (SAN-DO)
11/22/2005
53UC12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS)
118NOT LISTED
San Francisco District Office (SAN-DO)
11/18/2005
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
San Francisco District Office (SAN-DO)
11/18/2005
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
San Francisco District Office (SAN-DO)
11/18/2005
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
San Francisco District Office (SAN-DO)
11/18/2005
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
San Francisco District Office (SAN-DO)
11/18/2005
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
San Francisco District Office (SAN-DO)
11/18/2005
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
San Francisco District Office (SAN-DO)
11/18/2005
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
San Francisco District Office (SAN-DO)
11/14/2005
63VBL99DEPIGMENTOR N.E.C.
118NOT LISTED
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Gerden Pharmaceutical Laboratori's FDA import refusal history?

Gerden Pharmaceutical Laboratori (FEI: 3005187766) has 11 FDA import refusal record(s) in our database, spanning from 11/14/2005 to 11/22/2005.

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. Gerden Pharmaceutical Laboratori's FEI number is 3005187766.

What types of violations has Gerden Pharmaceutical Laboratori received?

Gerden Pharmaceutical Laboratori has been cited for 2 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 Gerden Pharmaceutical Laboratori come from?

All FDA import refusal data for Gerden Pharmaceutical Laboratori 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.