KBI Biopharma, Inc.
FDA inspection history in Boulder, Colorado, 2020 to 2021
- 2
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020–21Two Form 483s, at Boulder, Colorado.
- 2021The longest 483 on file: 2 observations over 3 pages at Boulder, Colorado.
Cited most
Across all KBI Biopharma observations on file
- 21 CFR 211.192Production record review1
- 21 CFR 211.67Equipment cleaning and maintenance1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete KBI Biopharma file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Boulder, Colorado
Two Form 483s · 2020 to 2021 · 3 observations
Latest: Form 483, Dec 3, 2021 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-12-03 | 483 Form 483 | Boulder, Colorado | 2 | $99 |
| 2020-03-06 | 483 Form 483 | Boulder, Colorado | 1 | $99 |
Investigators on these documents
Beth A. Enright (1)Leonard K. Klysz (1)Michael A. Charles (1)Nicholas L. Hunt (1)
FEI number 3011326133 · most recent document Dec 3, 2021
About KBI Biopharma, Inc.
How many FDA Form 483s has KBI Biopharma, Inc. received?
FDA Intel has 2 Form 483s on file for KBI Biopharma, Inc.; the most recent is dated Dec 3, 2021.
When was KBI Biopharma, Inc. last inspected by FDA?
The most recent FDA inspection document on file for KBI Biopharma, Inc. is a Form 483 dated Dec 3, 2021, for the site in Boulder, Colorado.
What did FDA cite at KBI Biopharma, Inc.?
The regulations cited most in the observations on file for KBI Biopharma, Inc. are 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.67 (Equipment cleaning and maintenance), 1 time; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 1 time.