KedPlasma LLC
Form 483 issued March 21, 2019
- Inspection
- Mar 19 – Mar 21, 2019
- Investigators
- Christopher Cox· Cordelia J. Brammer· Judy E. Ciaraldi
- Observations
- 2
- Pages
- 4
- FEI number
- 3014545171
In short: On March 21, 2019, FDA issued a Form 483 with 2 observations to KedPlasma LLC (FEI 3014545171) after an inspection that ran Mar 19 – Mar 21, 2019. The investigators were Christopher Cox, Cordelia J. Brammer and Judy E. Ciaraldi. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 630.40 (requirements for notifying deferred donors).
At a glance
Observations span 1 system, led by biologics cgmp.
Most cited: 21 CFR 630.40 (1×) · 606.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 630.40
The firm does not always make reasonable attempts to notify donors who are deferred based on…
- 02
The firm does not always follow their written standard operating procedures for all steps in the…
This inspection in context
Questions about this 483
What did FDA find at KedPlasma LLC?
FDA listed 2 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 630.40 (requirements for notifying deferred donors). The opening words of each observation are shown on this page.
Who inspected KedPlasma LLC?
Christopher Cox, Cordelia J. Brammer and Judy E. Ciaraldi are named on this Form 483, for the inspection of Mar 19 – Mar 21, 2019. Each investigator has a profile showing what they cite most.
When was KedPlasma LLC inspected by FDA?
The inspection ran Mar 19 – Mar 21, 2019, and the Form 483 is dated March 21, 2019.
How do I get the full Form 483 for KedPlasma LLC?
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.