KVP Pharma Veterinär Produkte GmbH

Form 483 issued March 24, 2023 · Kiel, Germany

Inspection
Mar 20 – Mar 24, 2023
Observations
1
Pages
2
FEI number
3004159824

In short: On March 24, 2023, FDA issued a Form 483 with 1 observation to KVP Pharma Veterinär Produkte GmbH in Kiel, Germany (FEI 3004159824) after an inspection that ran Mar 20 – Mar 24, 2023. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).

At a glance

1 of 1 observations on this 483 concern laboratory controls.

Laboratory controls1

Most cited: 21 CFR 211.160(b) (1×)

What FDA observed

Preview: the opening words of each observation
  1. 01

    Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure…

The full 483

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This inspection in context

Questions about this 483

What did FDA find at KVP Pharma Veterinär Produkte GmbH?

FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.

When was KVP Pharma Veterinär Produkte GmbH inspected by FDA?

The inspection ran Mar 20 – Mar 24, 2023, and the Form 483 is dated March 24, 2023.

How do I get the full Form 483 for KVP Pharma Veterinär Produkte GmbH?

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