Company
United StatesApace Packaging LLC, Fountain Run, KY – FDA Inspections
Inspection records and compliance data for Apace Packaging LLC in Fountain Run, Kentucky. 7 FDA inspections on record, last inspected January 13, 2022.
Company Profile
This profile covers Apace Packaging LLC based in Fountain Run, Kentucky, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 3
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected December 11, 2008. Last inspected January 13, 2022.
Most cited issue areas
- Calibration/Inspection/Checking not done2 inspections
- Absence of Written Procedures1 inspection
- Approve or reject procedures or specs1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 13, 2022 | NAI | Human Drugs · Drug Quality Assurance | 1161276 |
| January 17, 2019 | Not classified | Human Drugs | 1081431 |
| August 4, 2016 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 983050 |
| July 30, 2013 | NAI | Human Drugs · Drug Quality Assurance | 844093 |
| August 24, 2012 | NAI | Human Drugs · Drug Quality Assurance | 796038 |
| September 23, 2011 | VAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 743880 |
| December 11, 2008 | VAI | Human Drugs · Drug Quality Assurance | 553845 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Apace Packaging LLC
FEI Number
3005336862
Address
12954 Fountain Run Rd, Fountain Run, Kentucky 42133, United States
Country
United States
ID: 7e233bce-241d-4bea-af98-13d309bc2cdd