KBI Biopharma, Inc.
Form 483 issued December 3, 2021 · Boulder, Colorado
- Inspection
- Nov 30 – Dec 3, 2021
- Investigators
- Michael A. Charles· Nicholas L. Hunt
- Observations
- 2
- Pages
- 3
- FEI number
- 3011326133
In short: On December 3, 2021, FDA issued a Form 483 with 2 observations to KBI Biopharma, Inc. in Boulder, Colorado (FEI 3011326133) after an inspection that ran Nov 30 – Dec 3, 2021. The investigators were Michael A. Charles and Nicholas L. Hunt. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations conducted are not always complete to include systematic investigations of root causes to identify sources…
- 02
Procedures for maintenance of…
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmKBI Biopharma, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KBI Biopharma, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected KBI Biopharma, Inc.?
Michael A. Charles and Nicholas L. Hunt are named on this Form 483, for the inspection of Nov 30 – Dec 3, 2021. Each investigator has a profile showing what they cite most.
When was KBI Biopharma, Inc. inspected by FDA?
The inspection ran Nov 30 – Dec 3, 2021, and the Form 483 is dated December 3, 2021.
How do I get the full Form 483 for KBI Biopharma, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.