Laurus Labs Limited (Unit-5)

Form 483 issued October 28, 2022 · Anakapalli, India

Inspection
Oct 24 – Oct 28, 2022
Observations
1
Pages
1
FEI number
3017037090

In short: On October 28, 2022, FDA issued a Form 483 with 1 observation to Laurus Labs Limited (Unit-5) in Anakapalli, Andhra Pradesh (FEI 3017037090) after an inspection that ran Oct 24 – Oct 28, 2022. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.44 (lighting).

At a glance

1 of 1 observations on this 483 concern facilities & equipment.

Facilities & equipment1

Most cited: 21 CFR 211.44 (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

    Adequate lighting is not…

The full 483

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This inspection in context

Questions about this 483

What did FDA find at Laurus Labs Limited (Unit-5)?

FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.44 (lighting). The opening words of each observation are shown on this page.

When was Laurus Labs Limited (Unit-5) inspected by FDA?

The inspection ran Oct 24 – Oct 28, 2022, and the Form 483 is dated October 28, 2022.

How do I get the full Form 483 for Laurus Labs Limited (Unit-5)?

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