Mensajeria Y Empaques Saavel, S.A.
⚠️ Moderate Risk
FEI: 3006293121 • D.F., D.F. • MEXICO
FEI Number
3006293121
Location
D.F., D.F.
Country
MEXICOAddress
Av. Tlahuac # 1577 Loc. 104 Acol., , D.F., D.F., 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).
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).
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/2/2007 | 56EDK80TETRACYCLINE (TETRACYCLINES) | Cincinnati District Office (CIN-DO) | |
| 8/13/2007 | 80KZHINTRODUCER, SYRINGE NEEDLE | Cincinnati District Office (CIN-DO) | |
| 8/13/2007 | 60LCA14CARBAMAZEPINE (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/3/2007 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Mensajeria Y Empaques Saavel, S.A.'s FDA import refusal history?
Mensajeria Y Empaques Saavel, S.A. (FEI: 3006293121) has 4 FDA import refusal record(s) in our database, spanning from 7/3/2007 to 11/2/2007.
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. Mensajeria Y Empaques Saavel, S.A.'s FEI number is 3006293121.
What types of violations has Mensajeria Y Empaques Saavel, S.A. received?
Mensajeria Y Empaques Saavel, S.A. has been cited for 5 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 Mensajeria Y Empaques Saavel, S.A. come from?
All FDA import refusal data for Mensajeria Y Empaques Saavel, S.A. 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.