Alivira Animal Health Limited

Form 483 issued September 22, 2023 · Visakhapatnam, India

Observations
1
Pages
1
FEI number
3011747378

In short: On September 22, 2023, FDA issued a Form 483 with 1 observation to Alivira Animal Health Limited in Visakhapatnam, Andhra Pradesh (FEI 3011747378). Most observations concern production; the most-cited regulation is 21 CFR 211.188 (batch production and control records).

At a glance

1 of 1 observations on this 483 concern production.

Production1

Most cited: 21 CFR 211.188 (1×) · 211.192 (1×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01

    There is a failure to document and thoroughly review each significant step in your Batch Manufacturing…

The full 483

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This inspection in context

Questions about this 483

What did FDA find at Alivira Animal Health Limited?

FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.

When was Alivira Animal Health Limited inspected by FDA?

This Form 483 is dated September 22, 2023.

How do I get the full Form 483 for Alivira Animal Health Limited?

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