Company
United StatesSteritec Products Mfg. Co., Inc., Englewood, CO – FDA Inspections
Inspection records and compliance data for Steritec Products Mfg. Co., Inc. in Englewood, Colorado. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected December 01, 2022.
Company Profile
This profile covers Steritec Products Mfg. Co., Inc. based in Englewood, Colorado, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 2, 2009. Last inspected December 1, 2022.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of or inadequate receiving acceptance procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 1, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1192098 |
| February 1, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1000027 |
| May 1, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 831157 |
| August 12, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 675641 |
| June 2, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 585881 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Steritec Products Mfg. Co., Inc.
FEI Number
1000125215
Address
74 Inverness Dr E, Englewood, Colorado 80112, United States
Country
United States
ID: 5c4ae5a4-e14a-4059-9ffd-85b7697464c8