Pm Empaques Y Envios Sa De Cv
⚠️ High Risk
FEI: 3006221619 • Cholulacholula • MEXICO
FEI Number
3006221619
Location
Cholulacholula
Country
MEXICOAddress
Av Hidalgo No 716 Local 2centrocholula, , Cholulacholula, , Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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 |
|---|---|---|---|
| 6/11/2007 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/11/2007 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/11/2007 | 66VCK99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 6/11/2007 | 66VCK99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 6/11/2007 | 66VCK99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 5/21/2007 | 61HCE32NITROFURANTOIN (ANTI-BACTERIAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/21/2007 | 56BDE05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/21/2007 | 61GCA85OFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/21/2007 | 56JCE20CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/21/2007 | 54AGK99VITAMIN, N.E.C. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Pm Empaques Y Envios Sa De Cv's FDA import refusal history?
Pm Empaques Y Envios Sa De Cv (FEI: 3006221619) has 10 FDA import refusal record(s) in our database, spanning from 5/21/2007 to 6/11/2007.
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. Pm Empaques Y Envios Sa De Cv's FEI number is 3006221619.
What types of violations has Pm Empaques Y Envios Sa De Cv received?
Pm Empaques Y Envios Sa De Cv 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 Pm Empaques Y Envios Sa De Cv come from?
All FDA import refusal data for Pm Empaques Y Envios 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.