Laurus Labs Limited
Form 483 issued February 10, 2023 · Anakapalli, India
- Inspection
- Feb 6 – Feb 10, 2023
- Observations
- 2
- Pages
- 2
- FEI number
- 3011538548
In short: On February 10, 2023, FDA issued a Form 483 with 2 observations to Laurus Labs Limited in Anakapalli, Andhra Pradesh (FEI 3011538548) after an inspection that ran Feb 6 – Feb 10, 2023. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.56 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained. in…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
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 facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
When was Laurus Labs Limited inspected by FDA?
The inspection ran Feb 6 – Feb 10, 2023, and the Form 483 is dated February 10, 2023.
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.