Company
United StatesInopak Ltd, Ringwood, NJ – FDA Inspections
Inspection records and compliance data for Inopak Ltd in Ringwood, New Jersey. 7 FDA inspections on record (3 OAI), 3 Form 483s, 1 warning letter, last inspected August 03, 2023.
Company Profile
This profile covers Inopak Ltd based in Ringwood, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 3
- VAI
- 4
- NAI
- 0
- Form 483s
- 3
- Warning letters
- 1
First inspected August 21, 2009. Last inspected August 3, 2023.
Most cited issue areas
- Control procedures to monitor and validate performance2 inspections
- GMP Training Frequency2 inspections
- Identity Testing of Each Component2 inspections
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 3, 2023 | OAI | Human Drugs · Drug Quality Assurance | 1214661 |
| June 18, 2021 | OAI | Human Drugs · Drug Quality Assurance | 1144199 |
| July 20, 2018 | OAI | Human Drugs · Drug Quality Assurance | 1059942 |
| March 24, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1010061 |
| February 11, 2015 | VAI | Human Drugs · Drug Quality Assurance | 913858 |
| September 11, 2012 | VAI | Human Drugs · Drug Quality Assurance | 797562 |
| August 21, 2009 | VAI | Human Drugs · Drug Quality Assurance | 605846 |
FDA documents
Form 483s (2)
Warning Letters (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Inopak Ltd
FEI Number
1000122232
Address
24 Executive Pkwy, Ringwood, New Jersey 07456, United States
Country
United States
ID: 0e7c501d-9636-4cc2-b8dc-f2a1cb0c3f44