FEI 3009963993
Azer Scientific, Inc.
701 Hemlock Rd, Morgantown, PA, US
MDR events7All time
Recalls2All time
Registered products63
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
63 product codes
Recent MDR events
7 on file
- 480 ML HALF-FILLED 10% NEUTRAL BUFFERED FORMALINAug 7, 2025Malfunction22736846
- GLUCOSE TOLERANCE BEVERAGENov 20, 2024Malfunction20733529
- PRE-FILLED FORMALINSep 13, 2024Malfunction20211219
- VACUTAINERSep 22, 2022MalfunctionMW5112239
- BUFFERED SALINE SOLUTION 0.85%Jan 7, 2022MalfunctionMW5106523
- BUFFERED SALINE SOLUTION 0.85%Jan 7, 2022MalfunctionMW5106524
- BUFFERED SALINE SOLUTION 0.85% SPECIMEN CONTAINERJan 5, 2022MalfunctionMW5106480
Compliance history
Matched by FEI 3009963993.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Dec 4, 2023
Compliance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.198(a)Dec 4, 2023
Complaints
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.