HKM Farmacia de Manipulacao Ltda
🚨 Critical Risk
FEI: 3027591224 • Palhoca, Santa Catarina • BRAZIL
FEI Number
3027591224
Location
Palhoca, Santa Catarina
Country
BRAZILAddress
Avenida Gentil Reinaldo Cordioli, 161, Jardim Eldorado, Palhoca, Santa Catarina, Brazil
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/24/2025 | 64GDA07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 65JDA31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 65DCY99OXYTOCIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/13/2025 | 66JCE02LIOTHYRONINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/13/2025 | 66JCE01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2025 | 54YFE08COENZYME Q10 (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2025 | 65JCY31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2025 | 54FGE41CAT'S CLAW (UNAD'GATO), (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2025 | 54AGE12FOLIC ACID (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2025 | 66JCE01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2025 | 60NCE20DEHYDROEPIANDROSTERONE (ANDROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2025 | 65JCE31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2025 | 65JCK31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2025 | 61WDE23POTASSIUM IODIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2025 | 64EDE02PANCREATIN (ENZYME) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2025 | 64LDE58PREGNENOLONE SUCCINATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2025 | 66JDE01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2025 | 65VDE08CHLORAL BETAINE (SEDATIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HKM Farmacia de Manipulacao Ltda's FDA import refusal history?
HKM Farmacia de Manipulacao Ltda (FEI: 3027591224) has 18 FDA import refusal record(s) in our database, spanning from 7/21/2025 to 9/24/2025.
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. HKM Farmacia de Manipulacao Ltda's FEI number is 3027591224.
What types of violations has HKM Farmacia de Manipulacao Ltda received?
HKM Farmacia de Manipulacao Ltda 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 HKM Farmacia de Manipulacao Ltda come from?
All FDA import refusal data for HKM Farmacia de Manipulacao Ltda 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.