Company
United StatesMon Healthcare, Inc., Morgantown, WV – FDA Inspections
Inspection records and compliance data for Mon Healthcare, Inc. in Morgantown, West Virginia. 2 FDA inspections on record, last inspected November 07, 2012.
Company Profile
This profile covers Mon Healthcare, Inc. based in Morgantown, West Virginia, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected October 15, 2010. Last inspected November 7, 2012.
Most cited issue areas
- Calibration - at intervals, written program, remedial action1 inspection
- Incoming lots - conformance to written specs-1 inspection
- Lack of quality control unit1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 7, 2012 | NAI | Human Drugs · Drug Quality Assurance | 806829 |
| October 15, 2010 | VAI | Human Drugs · Drug Quality Assurance | 685509 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Mon Healthcare, Inc.
FEI Number
1121728
Address
600 Business Park Dr, Morgantown, West Virginia 26505, United States
Country
United States
ID: 3ffadf86-3a3a-4607-9f43-5aa68de4c89f