Company
United StatesSterigenics U.S., LLC, Rockaway, NJ – FDA Inspections
Inspection records and compliance data for Sterigenics U.S., LLC in Rockaway, New Jersey. 6 FDA inspections on record, 1 Form 483, last inspected August 15, 2023.
Company Profile
This profile covers Sterigenics U.S., LLC based in Rockaway, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 1
- NAI
- 5
- Form 483s
- 1
- Warning letters
- 0
First inspected November 20, 2009. Last inspected August 15, 2023.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 15, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1215298 |
| March 2, 2020 | NAI | Animal Drugs & Feeds · Monitoring of Marketed Animal Drugs, Feed, and Devices | 1123488 |
| October 31, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1081756 |
| May 13, 2016 | NAI | Human Drugs · Drug Quality Assurance | 969813 |
| December 14, 2012 | NAI | Foods & Cosmetics, Human Drugs, Medical Devices & Rad Health · Foodborne Biological Hazards | 810569 |
| November 20, 2009 | NAI | Foods & Cosmetics, Human Drugs, Medical Devices & Rad Health · Foodborne Biological Hazards | 629535 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Sterigenics U.S., LLC
FEI Number
2219920
Address
108 Lake Denmark Rd, Rockaway, New Jersey 07866, United States
Country
United States
ID: bb2ed1d7-f397-44d3-ba4a-7f0ae5ae49b1