Company
United StatesFujiFilm Ultra Pure Solutions, Inc., Carrollton, TX – FDA Inspections
Inspection records and compliance data for FujiFilm Ultra Pure Solutions, Inc. in Carrollton, Texas. 3 FDA inspections on record, 1 Form 483, last inspected January 15, 2020.
Company Profile
This profile covers FujiFilm Ultra Pure Solutions, Inc. based in Carrollton, Texas, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected September 1, 2010. Last inspected January 15, 2020.
Most cited issue areas
- Batch production and Batch Control Record Requirements1 inspection
- Buildings not maintained in good state of repair1 inspection
- Lack of quality control unit1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 15, 2020 | NAI | Human Drugs · Drug Quality Assurance | 1116146 |
| January 12, 2017 | VAI | Human Drugs · Drug Quality Assurance | 996404 |
| September 1, 2010 | NAI | Human Drugs · Drug Quality Assurance | 678306 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
FujiFilm Ultra Pure Solutions, Inc.
FEI Number
3004542945
Address
1200 W Jackson Rd, Carrollton, Texas 75006, United States
Country
United States
ID: 958bdfeb-69bc-412d-b79e-2cfcb8615ef6