Laurus Labs Limited
Form 483 issued August 18, 2017 · Anakapalli, India
- Inspection
- Aug 14 – Aug 18, 2017
- Observations
- 2
- Pages
- 9
- FEI number
- 3007083664
In short: On August 18, 2017, FDA issued a Form 483 with 2 observations to Laurus Labs Limited in Anakapalli, Andhra Pradesh (FEI 3007083664) after an inspection that ran Aug 14 – Aug 18, 2017. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Out of Specification (OOS)…
- 02
Qualification of Laboratory Instrument…
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 quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Laurus Labs Limited inspected by FDA?
The inspection ran Aug 14 – Aug 18, 2017, and the Form 483 is dated August 18, 2017.
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.