Laurus Labs Limited
Form 483 issued June 14, 2019 · Anakapalli, India
- Inspection
- Jun 10 – Jun 14, 2019
- Observations
- 2
- Pages
- 2
- FEI number
- 3007083664
In short: On June 14, 2019, FDA issued a Form 483 with 2 observations to Laurus Labs Limited in Anakapalli, Andhra Pradesh (FEI 3007083664) after an inspection that ran Jun 10 – Jun 14, 2019. Most observations concern production.
At a glance
2 of 2 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to adequately document…
- 02
Failure to maintain complete…
This inspection in context
Questions about this 483
What did FDA find at Laurus Labs Limited?
FDA listed 2 observations on this Form 483, mostly about production. The opening words of each observation are shown on this page.
When was Laurus Labs Limited inspected by FDA?
The inspection ran Jun 10 – Jun 14, 2019, and the Form 483 is dated June 14, 2019.
How do I get the full Form 483 for Laurus Labs Limited?
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.