Fisher & Paykel Healthcare S.a. De C.v.
⚠️ Moderate Risk
FEI: 3008264065 • Tijuana, Baja California • MEXICO
FEI Number
3008264065
Location
Tijuana, Baja California
Country
MEXICOAddress
Avenida Todos Santos # 12831, Conjunto Habitacional Terrazas Del Pacif, Tijuana, Baja California, 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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
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 |
|---|---|---|---|
| 1/11/2022 | 73BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 1/11/2022 | 73BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 1/11/2022 | 73BYGMASK, OXYGEN | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 1/11/2022 | 73BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 1/11/2022 | 73BZDVENTILATOR, NON-CONTINUOUS (RESPIRATOR) | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 1/11/2022 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 1/11/2022 | 73BZOSET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 1/11/2022 | 73BZOSET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 1/11/2022 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 2/22/2013 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | Florida District Office (FLA-DO) | |
| 2/22/2013 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Fisher & Paykel Healthcare S.a. De C.v.'s FDA import refusal history?
Fisher & Paykel Healthcare S.a. De C.v. (FEI: 3008264065) has 11 FDA import refusal record(s) in our database, spanning from 2/22/2013 to 1/11/2022.
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. Fisher & Paykel Healthcare S.a. De C.v.'s FEI number is 3008264065.
What types of violations has Fisher & Paykel Healthcare S.a. De C.v. received?
Fisher & Paykel Healthcare S.a. De C.v. has been cited for 3 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 Fisher & Paykel Healthcare S.a. De C.v. come from?
All FDA import refusal data for Fisher & Paykel Healthcare 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.