Company
United StatesBioelements Inc., Colorado Springs, CO – FDA Inspections
Inspection records and compliance data for Bioelements Inc. in Colorado Springs, Colorado. 4 FDA inspections on record, 1 Form 483, last inspected October 27, 2021.
Company Profile
This profile covers Bioelements Inc. based in Colorado Springs, Colorado, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected February 11, 2010. Last inspected October 27, 2021.
Most cited issue areas
- Procedures not in writing, fully followed2 inspections
- Comparison of Test Results to Specifications1 inspection
- Failing drug products not rejected1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 27, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1155328 |
| February 10, 2017 | NAI | Foods & Cosmetics, Human Drugs · Colors and Cosmetics Technology | 1007571 |
| September 6, 2012 | VAI | Human Drugs · Drug Quality Assurance | 797685 |
| February 11, 2010 | NAI | Human Drugs · Drug Quality Assurance | 645568 |
FDA documents
Form 483s (1)
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Company Information
Name
Bioelements Inc.
FEI Number
3008137936
Address
3650 E Boulder St, Colorado Springs, Colorado 80909, United States
Country
United States
ID: 7257e8b0-bd4b-4eda-a8a2-80e51a2e9365