Laurus Labs Limited
Form 483 issued January 31, 2025 · Anakapalli, India
- Inspection
- Jan 27 – Jan 31, 2025
- Investigators
- Jessica S. Estriplet· Olumide A. Akinyemi
- Observations
- 2
- Pages
- 2
- FEI number
- 3014255847
In short: On January 31, 2025, FDA issued a Form 483 with 2 observations to Laurus Labs Limited in Anakapalli, Andhra Pradesh (FEI 3014255847) after an inspection that ran Jan 27 – Jan 31, 2025. The investigators were Jessica S. Estriplet and Olumide A. Akinyemi. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.100 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures, including changes thereof, are not drafted, reviewed and approved by appropriate organization units, and…
- 02
You failed to ensure that equipment qualification protocols are reviewed and approved by the quality unit…
This inspection in context
Jessica S. Estriplet
18 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmLaurus Labs Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Laurus Labs Limited?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Laurus Labs Limited?
Jessica S. Estriplet and Olumide A. Akinyemi are named on this Form 483, for the inspection of Jan 27 – Jan 31, 2025. Each investigator has a profile showing what they cite most.
When was Laurus Labs Limited inspected by FDA?
The inspection ran Jan 27 – Jan 31, 2025, and the Form 483 is dated January 31, 2025.
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.