MSN Life Sciences Private Limited
Form 483 issued September 13, 2024 · Chandampet, India
- Inspection
- Sep 9 – Sep 13, 2024
- Investigator
- Steven A. Brettler
- Observations
- 1
- Pages
- 3
- FEI number
- 3011543392
In short: On September 13, 2024, FDA issued a Form 483 with 1 observation to MSN Life Sciences Private Limited in Chandampet, India (FEI 3011543392) after an inspection that ran Sep 9 – Sep 13, 2024. The investigator was Steven A. Brettler. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 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
Your firm failed to thoroughly investigate critical deviations and/or the failure(s) of a…
This inspection in context
Steven A. Brettler
15 documents · 2021–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Florida.
The firmMSN Life Sciences Private Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MSN Life Sciences Private Limited?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected MSN Life Sciences Private Limited?
Steven A. Brettler is named on this Form 483, for the inspection of Sep 9 – Sep 13, 2024. Each investigator has a profile showing what they cite most.
When was MSN Life Sciences Private Limited inspected by FDA?
The inspection ran Sep 9 – Sep 13, 2024, and the Form 483 is dated September 13, 2024.
How do I get the full Form 483 for MSN Life Sciences Private 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.