Lantech Pharmaceuticals Limited
Form 483 issued September 12, 2023 · Srikakulam, India
- Inspection
- Sep 7 – Sep 12, 2023
- Investigator
- Guerlain Ulysse
- Observations
- 3
- Pages
- 3
- FEI number
- 3012390454
In short: On September 12, 2023, FDA issued a Form 483 with 3 observations to Lantech Pharmaceuticals Limited in Srikakulam, Andhra Pradesh (FEI 3012390454) after an inspection that ran Sep 7 – Sep 12, 2023. The investigator was Guerlain Ulysse. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm's cleaning of…
- 02
Your quality unit lacks…
- 03
Strict Controls are not exercised…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmLantech Pharmaceuticals Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lantech Pharmaceuticals Limited?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Lantech Pharmaceuticals Limited?
Guerlain Ulysse is named on this Form 483, for the inspection of Sep 7 – Sep 12, 2023. Each investigator has a profile showing what they cite most.
When was Lantech Pharmaceuticals Limited inspected by FDA?
The inspection ran Sep 7 – Sep 12, 2023, and the Form 483 is dated September 12, 2023.
How do I get the full Form 483 for Lantech Pharmaceuticals 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.