Nancy Manoloto
⚠️ Moderate Risk
FEI: 3005085851 • Manila • PHILIPPINES
FEI Number
3005085851
Location
Manila
Country
PHILIPPINESAddress
235 M.L. Quezon St, , Manila, , Philippines
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/12/2005 | 66VCE99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 5/12/2005 | 62GDE99ANTI-INFLAMMATORY N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/12/2005 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 5/12/2005 | 56BCE03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Nancy Manoloto's FDA import refusal history?
Nancy Manoloto (FEI: 3005085851) has 4 FDA import refusal record(s) in our database, spanning from 5/12/2005 to 5/12/2005.
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. Nancy Manoloto's FEI number is 3005085851.
What types of violations has Nancy Manoloto received?
Nancy Manoloto 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 Nancy Manoloto come from?
All FDA import refusal data for Nancy Manoloto 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.