Company
United StatesTOLMAR 1413 ACQUISITION, LLC, Fort Collins, CO – FDA Inspections
Inspection records and compliance data for TOLMAR 1413 ACQUISITION, LLC in Fort Collins, Colorado. 2 FDA inspections on record, 1 Form 483, last inspected September 11, 2018.
Company Profile
This profile covers TOLMAR 1413 ACQUISITION, LLC based in Fort Collins, Colorado, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected June 18, 2015. Last inspected September 11, 2018.
Most cited issue areas
- Cleaning SOPs/schedules1 inspection
- Control procedures to monitor and validate performance1 inspection
- Procedures for sterile drug products1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 11, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1065361 |
| June 18, 2015 | VAI | Human Drugs · Drug Quality Assurance | 930611 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
TOLMAR 1413 ACQUISITION, LLC
FEI Number
3008191575
Address
1413 Duff Dr, Fort Collins, Colorado 80524, United States
Country
United States
ID: 1220c6fb-2048-406a-a924-4a2e1431ecaf