Company
United StatesQualimax LLC, Ridgefield, NJ – FDA Inspections
Inspection records and compliance data for Qualimax LLC in Ridgefield, New Jersey. 4 FDA inspections on record, last inspected June 13, 2024.
Company Profile
This profile covers Qualimax LLC based in Ridgefield, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected October 8, 2008. Last inspected June 13, 2024.
Most cited issue areas
- Calibration - at intervals, written program, remedial action1 inspection
- Procedures not in writing, fully followed1 inspection
- Scientifically sound laboratory controls1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 13, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1241221 |
| June 24, 2016 | NAI | Human Drugs · Drug Quality Assurance | 976571 |
| March 6, 2013 | VAI | Human Drugs · Drug Quality Assurance | 820882 |
| October 8, 2008 | NAI | Human Drugs · Drug Quality Assurance | 541636 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Qualimax LLC
FEI Number
3004599007
Address
65 Railroad Ave Ste 205, Ridgefield, New Jersey 07657, United States
Country
United States
ID: f55d9729-a19e-450f-938d-552b6c0e3eb0