Company
United StatesGenPak Solutions LLC, Hilliard, OH – FDA Inspections
Inspection records and compliance data for GenPak Solutions LLC in Hilliard, Ohio. 4 FDA inspections on record (1 OAI), 1 Form 483, last inspected June 15, 2017.
Company Profile
This profile covers GenPak Solutions LLC based in Hilliard, Ohio, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected August 23, 2011. Last inspected June 15, 2017.
Most cited issue areas
- Absence of Written Procedures2 inspections
- Expiration date lacking2 inspections
- Procedures not in writing, fully followed2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 15, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1014779 |
| August 12, 2015 | OAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 939392 |
| May 10, 2013 | VAI | Human Drugs · Drug Quality Assurance | 833734 |
| August 23, 2011 | NAI | Human Drugs · Drug Quality Assurance | 740965 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
GenPak Solutions LLC
FEI Number
3008815009
Address
4324 Reynolds Dr, Hilliard, Ohio 43026, United States
Country
United States
ID: 13198085-f8e3-47a5-abc8-bfc42ee9309e