MANUFACTURA SAYES SA DE CV
⚠️ Moderate Risk
FEI: 3013196075 • Puebla • MEXICO
FEI Number
3013196075
Location
Puebla
Country
MEXICOAddress
Pomaski No 202, Col Emil, Puebla, , Mexico
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/30/2020 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2020 | 62BCA12MEZLOCILLIN SODIUM MONOHYDRATE (ANTI-HYPERLIPIDEMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/31/2017 | 61PDK17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/16/2016 | 54ABB99VITAMIN, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MANUFACTURA SAYES SA DE CV's FDA import refusal history?
MANUFACTURA SAYES SA DE CV (FEI: 3013196075) has 4 FDA import refusal record(s) in our database, spanning from 3/16/2016 to 11/30/2020.
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. MANUFACTURA SAYES SA DE CV's FEI number is 3013196075.
What types of violations has MANUFACTURA SAYES SA DE CV received?
MANUFACTURA SAYES SA DE CV 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 MANUFACTURA SAYES SA DE CV come from?
All FDA import refusal data for MANUFACTURA SAYES SA DE CV 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.