Company
United StatesPuraCap Laboratories LLC, Franklin, KY – FDA Inspections
Inspection records and compliance data for PuraCap Laboratories LLC in Franklin, Kentucky. 3 FDA inspections on record, last inspected January 22, 2019.
Company Profile
This profile covers PuraCap Laboratories LLC based in Franklin, Kentucky, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected March 17, 2016. Last inspected January 22, 2019.
Most cited issue areas
- Failure to develop written procedures1 inspection
- Late submission of 15-day report1 inspection
- Late submission of annual safety reports1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 22, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1078575 |
| July 11, 2017 | Not classified | Human Drugs | 1018341 |
| March 17, 2016 | VAI | Human Drugs · Bioresearch Monitoring | 963506 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
PuraCap Laboratories LLC
FEI Number
3005916122
Address
301 Robey St, Franklin, Kentucky 42134, United States
Country
United States
ID: 87e77970-08da-4361-a42f-3b4716712d98