KBI Biopharma, Inc.
FDA inspection history in Durham, North Carolina, 2020 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Durham, North Carolina.
- 2020The longest 483 on file: 5 observations over 4 pages at Durham, North Carolina.
- 2024One Form 483, at Durham, North Carolina.
Cited most
Across all KBI Biopharma observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.25Personnel qualifications1
- 21 CFR 211.46Ventilation, air filtration, air heating and cooling1
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
Durham, North Carolina
Two Form 483s · 2020 to 2024 · 6 observations
Latest: Form 483, Jun 18, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-18 | 483 Form 483 | Durham, North Carolina | 1 | $99 |
| 2020-09-29 | 483 Form 483 | Durham, North Carolina | 5 | $99 |
Investigators on these documents
FEI number 3004638264 · most recent document Jun 18, 2024
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 Jun 18, 2024.
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 Jun 18, 2024, for the site in Durham, North Carolina.
What did FDA cite at KBI Biopharma, Inc.?
The regulations cited most in the observations on file for KBI Biopharma, Inc. are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.