KBI Biopharma, Inc.
Form 483 issued March 6, 2020 · Boulder, Colorado
- Inspection
- Mar 2 – Mar 6, 2020
- Investigators
- Beth A. Enright· Leonard K. Klysz
- Observations
- 1
- Pages
- 1
- FEI number
- 3011326133
In short: On March 6, 2020, FDA issued a Form 483 with 1 observation to KBI Biopharma, Inc. in Boulder, Colorado (FEI 3011326133) after an inspection that ran Mar 2 – Mar 6, 2020. The investigators were Beth A. Enright and Leonard K. Klysz.
What FDA observed
Preview: the opening words of each observation- 01
The characterization study performed to evaluate the (b)(4) of pegfilgrastim drug substance in (b)(4) bottles did…
This inspection in context
Questions about this 483
What did FDA find at KBI Biopharma, Inc.?
FDA listed 1 observation on this Form 483. The opening words of each observation are shown on this page.
Who inspected KBI Biopharma, Inc.?
Beth A. Enright and Leonard K. Klysz are named on this Form 483, for the inspection of Mar 2 – Mar 6, 2020. Each investigator has a profile showing what they cite most.
When was KBI Biopharma, Inc. inspected by FDA?
The inspection ran Mar 2 – Mar 6, 2020, and the Form 483 is dated March 6, 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.