Company
United StatesPure Chem Inc, Wentzville, MO – FDA Inspections
Inspection records and compliance data for Pure Chem Inc in Wentzville, Missouri. 2 FDA inspections on record, last inspected April 19, 2013.
Company Profile
This profile covers Pure Chem Inc based in Wentzville, Missouri, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected July 13, 2011. Last inspected April 19, 2013.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Adequate number of batches on stability1 inspection
- Calibration - at intervals, written program, remedial action1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 19, 2013 | VAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 828629 |
| July 13, 2011 | VAI | Human Drugs · Drug Quality Assurance | 733810 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Pure Chem Inc
FEI Number
3005425422
Address
117 Avalon Industrial Pkwy, Wentzville, Missouri 63385, United States
Country
United States
ID: 8085bf8a-d081-4ded-8dfd-d12cdcb58173