Company
United StatesCerapedics, Inc., Westminster, CO – FDA Inspections
Inspection records and compliance data for Cerapedics, Inc. in Westminster, Colorado. 7 FDA inspections on record, 1 Form 483, last inspected March 13, 2024.
Company Profile
This profile covers Cerapedics, Inc. based in Westminster, Colorado, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 6
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 2, 2010. Last inspected March 13, 2024.
Most cited issue areas
- Lack of or inadequate process validation3 inspections
- Software validation for automated processes2 inspections
- Equipment suitability & capability1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 13, 2024 | VAI | Medical Devices & Rad Health · Project Evaluation: Devices | 1233355 |
| October 24, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1107407 |
| December 9, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 995653 |
| June 5, 2015 | VAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 929211 |
| November 18, 2014 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 903948 |
| October 5, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 802389 |
| April 2, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 655394 |
FDA documents
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Company Information
Name
Cerapedics, Inc.
FEI Number
3007155473
Address
11025 Dover St Unit 1600, Westminster, Colorado 80021, United States
Country
United States
ID: f8796d53-5af2-45b4-9f6d-fb2bac4aeea1