DeGasa, S.A. de C.V.
⚠️ Moderate Risk
FEI: 6322 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
6322
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle Avenida Prolongacion Canal De Miramontes # 3775, Col. Los Colorines, Tlalpan, Ciudad De Mexico, Ciudad de Mexico, 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
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).
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).
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).
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 |
|---|---|---|---|
| 8/3/2012 | 80LLKNON-INFLATABLE COMPRESSION LEGGING | Florida District Office (FLA-DO) | |
| 8/3/2012 | 76EFNCOTTON, ROLL | Florida District Office (FLA-DO) | |
| 8/3/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 8/3/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 8/3/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is DeGasa, S.A. de C.V.'s FDA import refusal history?
DeGasa, S.A. de C.V. (FEI: 6322) has 5 FDA import refusal record(s) in our database, spanning from 8/3/2012 to 8/3/2012.
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. DeGasa, S.A. de C.V.'s FEI number is 6322.
What types of violations has DeGasa, S.A. de C.V. received?
DeGasa, S.A. de C.V. 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 DeGasa, S.A. de C.V. come from?
All FDA import refusal data for DeGasa, S.A. de C.V. 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.