KBI Biopharma, Inc.
Form 483 issued June 18, 2024 · Durham, North Carolina
- Observations
- 1
- Pages
- 1
- FEI number
- 3004638264
In short: On June 18, 2024, FDA issued a Form 483 with 1 observation to KBI Biopharma, Inc. in Durham, North Carolina (FEI 3004638264). Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.46 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Temperature qualifications of your GMP ambient storage…
This inspection in context
Questions about this 483
What did FDA find at KBI Biopharma, Inc.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling). The opening words of each observation are shown on this page.
When was KBI Biopharma, Inc. inspected by FDA?
This Form 483 is dated June 18, 2024.
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.