Sun Pharmaceutical Industries Limited- Madhuranthagam

Form 483 issued February 17, 2023 · Chengalpattu, India

Observations
1
Pages
1
FEI number
3007627683

In short: On February 17, 2023, FDA issued a Form 483 with 1 observation to Sun Pharmaceutical Industries Limited- Madhuranthagam in Chengalpattu, Tamil Nadu (FEI 3007627683). 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 (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

    Laboratory testing is not…

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This inspection in context

Questions about this 483

What did FDA find at Sun Pharmaceutical Industries Limited- Madhuranthagam?

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 Sun Pharmaceutical Industries Limited- Madhuranthagam inspected by FDA?

This Form 483 is dated February 17, 2023.

How do I get the full Form 483 for Sun Pharmaceutical Industries Limited- Madhuranthagam?

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