Haemonetics Mexico Manufacturing S. de R.L. de C.V.
⚠️ Moderate Risk
FEI: 3003327833 • Tijuana • MEXICO
FEI Number
3003327833
Location
Tijuana
Country
MEXICOAddress
Calle Colinas No. 11730, Parque Industrial El Florido, Tijuana, , 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
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 |
|---|---|---|---|
| 7/11/2011 | 80CAKMICROFILTER, BLOOD TRANSFUSION | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 7/11/2011 | 80CAKMICROFILTER, BLOOD TRANSFUSION | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 7/11/2011 | 80CAKMICROFILTER, BLOOD TRANSFUSION | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 7/11/2011 | 80CAKMICROFILTER, BLOOD TRANSFUSION | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Haemonetics Mexico Manufacturing S. de R.L. de C.V.'s FDA import refusal history?
Haemonetics Mexico Manufacturing S. de R.L. de C.V. (FEI: 3003327833) has 4 FDA import refusal record(s) in our database, spanning from 7/11/2011 to 7/11/2011.
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. Haemonetics Mexico Manufacturing S. de R.L. de C.V.'s FEI number is 3003327833.
What types of violations has Haemonetics Mexico Manufacturing S. de R.L. de C.V. received?
Haemonetics Mexico Manufacturing S. de R.L. de C.V. 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 Haemonetics Mexico Manufacturing S. de R.L. de C.V. come from?
All FDA import refusal data for Haemonetics Mexico Manufacturing S. de R.L. 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.