Katecho LLC
Form 483 issued July 16, 2021 · Des Moines, Iowa
- Inspection
- Jul 12 – Jul 16, 2021
- Observations
- 4
- Pages
- 5
- FEI number
- 1930027
In short: On July 16, 2021, FDA issued a Form 483 with 4 observations to Katecho LLC in Des Moines, Iowa (FEI 1930027) after an inspection that ran Jul 12 – Jul 16, 2021. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
Production & process controls and capa account for 4 of 4 observations.
Most cited: 21 CFR 820.75 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures for monitoring and control of process parameters for a validated process have…
- 03
Corrective and preventive action activities and/or results have…
- 04
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Questions about this 483
What did FDA find at Katecho LLC?
FDA listed 4 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
When was Katecho LLC inspected by FDA?
The inspection ran Jul 12 – Jul 16, 2021, and the Form 483 is dated July 16, 2021.
How do I get the full Form 483 for Katecho 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.