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General Drug And Co.Inc.

⚠️ Moderate Risk

FEI: 3003766284 • Mandaluyong • PHILIPPINES

FEI

FEI Number

3003766284

📍

Location

Mandaluyong

🇵🇭
🏢

Address

82 Mayflower St., , Mandaluyong, , Philippines

Moderate Risk

FDA Import Risk Assessment

33.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
12/16/2005
Latest Refusal
6/23/2005
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

1185×

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).

Refusal History

DateProductViolationsDivision
12/16/2005
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
San Francisco District Office (SAN-DO)
9/26/2005
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
118NOT LISTED
San Francisco District Office (SAN-DO)
9/26/2005
45CY99ANTIOXIDANTS (FOOD ADDITIVES FOR HUMAN USE)
118NOT LISTED
San Francisco District Office (SAN-DO)
9/26/2005
75JLOENZYMATIC (GLUTATHIONE REDUCTASE), GLUTATHIONE
118NOT LISTED
San Francisco District Office (SAN-DO)
6/23/2005
54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
118NOT LISTED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is General Drug And Co.Inc.'s FDA import refusal history?

General Drug And Co.Inc. (FEI: 3003766284) has 5 FDA import refusal record(s) in our database, spanning from 6/23/2005 to 12/16/2005.

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. General Drug And Co.Inc.'s FEI number is 3003766284.

What types of violations has General Drug And Co.Inc. received?

General Drug And Co.Inc. has been cited for 1 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 General Drug And Co.Inc. come from?

All FDA import refusal data for General Drug And Co.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.