Company
United StatesRed Star Contract Manufacturing, Inc., Larwill, IN – FDA Inspections
Inspection records and compliance data for Red Star Contract Manufacturing, Inc. in Larwill, Indiana. 2 FDA inspections on record, 1 Form 483, last inspected March 13, 2025.
Company Profile
This profile covers Red Star Contract Manufacturing, Inc. based in Larwill, Indiana, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected March 12, 2024. Last inspected March 13, 2025.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Contamination, mix ups, improper release1 inspection
- DHR content1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 13, 2025 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1263654 |
| March 12, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1230523 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Red Star Contract Manufacturing, Inc.
FEI Number
3009631939
Address
1560 N State Road 5, Larwill, Indiana 46764, United States
Country
United States
ID: 9c948d41-2a2e-40f9-ab53-a9aee2b71888