Pakmail Puebla
⚠️ High Risk
FEI: 3006000311 • Pueblapuebla • MEXICO
FEI Number
3006000311
Location
Pueblapuebla
Country
MEXICOAddress
Blvd. Hnos. Serdan # 126fracc. Real Del, , Pueblapuebla, , 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).
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 7/5/2007 | 64LCK03BETAMETHASONE (GLUCOCORTICOID) | Cincinnati District Office (CIN-DO) | |
| 7/3/2007 | 80FMFSYRINGE, PISTON | Cincinnati District Office (CIN-DO) | |
| 4/12/2007 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/12/2007 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/12/2007 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/12/2007 | 56ICL10ERYTHROMYCIN (MACROLIDES) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/12/2007 | 61GDL57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/12/2007 | 56BCA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/12/2007 | 61ECA08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/12/2007 | 54AEA05VITAMIN B12 (CYANOCOBALAMIN) | Cincinnati District Office (CIN-DO) | |
| 3/12/2007 | 64LDM38HYDROCORTISONE ACETATE (GLUCOCORTICOID) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/12/2007 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/12/2007 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Pakmail Puebla's FDA import refusal history?
Pakmail Puebla (FEI: 3006000311) has 13 FDA import refusal record(s) in our database, spanning from 3/12/2007 to 7/5/2007.
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. Pakmail Puebla's FEI number is 3006000311.
What types of violations has Pakmail Puebla received?
Pakmail Puebla has been cited for 6 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 Pakmail Puebla come from?
All FDA import refusal data for Pakmail Puebla 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.