KBI Biopharma, Inc.
Form 483 issued September 29, 2020 · Durham, North Carolina
- Inspection
- Sep 23 – Sep 29, 2020
- Investigator
- Viviana Matta
- Observations
- 5
- Pages
- 4
- FEI number
- 3004638264
In short: On September 29, 2020, FDA issued a Form 483 with 5 observations to KBI Biopharma, Inc. in Durham, North Carolina (FEI 3004638264) after an inspection that ran Sep 23 – Sep 29, 2020. The investigator was Viviana Matta. Most observations concern quality system and facilities & equipment.
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities of the quality control unit are not in…
- 02
The quality unit failed to ensure computerized systems have sufficient controls to prevent unauthorized access or…
- 03
The quality unit failed to ensure critical deviations and laboratory investigations…
- 04
The quality unit failed to ensure written standard…
This inspection in context
Viviana Matta
17 documents · 2012–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KBI Biopharma, Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected KBI Biopharma, Inc.?
Viviana Matta is named on this Form 483, for the inspection of Sep 23 – Sep 29, 2020. Each investigator has a profile showing what they cite most.
When was KBI Biopharma, Inc. inspected by FDA?
The inspection ran Sep 23 – Sep 29, 2020, and the Form 483 is dated September 29, 2020.
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.