Company
United StatesSTERITECH, INC., Salinas, PR – FDA Inspections
Inspection records and compliance data for STERITECH, INC. in Salinas, Puerto Rico. 5 FDA inspections on record, 2 Form 483s, last inspected December 08, 2023.
Company Profile
This profile covers STERITECH, INC. based in Salinas, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 2
- Warning letters
- 0
First inspected December 20, 2012. Last inspected December 8, 2023.
Most cited issue areas
- Documentation2 inspections
- Lack of or inadequate procedures2 inspections
- Production processes2 inspections
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 8, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1224385 |
| February 10, 2021 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1135465 |
| February 19, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1080319 |
| April 26, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1010928 |
| December 20, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 817958 |
FDA documents
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
STERITECH, INC.
FEI Number
2648209
Address
Carr. 701 Km 0.7 Lot 701, Salinas, Puerto Rico 00751, United States
Country
United States
ID: d82fe0a3-7c69-46ed-82ff-4a3beef4eab9