MSN Laboratories Private Limited
Form 483 issued June 23, 2016 · Sangareddy District, India
- Inspection
- Jun 20, 2011 – Jun 23, 2016
- Investigator
- Doan T. Nguyen
- Observations
- 2
- Pages
- 3
- FEI number
- 3005254981
In short: On June 23, 2016, FDA issued a Form 483 with 2 observations to MSN Laboratories Private Limited in Sangareddy District, Telangana (FEI 3005254981) after an inspection that ran Jun 20, 2011 – Jun 23, 2016. The investigator was Doan T. Nguyen. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 1 system, led by 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
Failure to conduct…
- 02
Your firm has failed to ensure that appropriate transport and storage…
This inspection in context
Doan T. Nguyen
8 documents · 2014–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Germany.
The firmMSN Laboratories Private Limited history
The site's inspection history, in date order.
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 Laboratories Private Limited?
FDA listed 2 observations 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 Laboratories Private Limited?
Doan T. Nguyen is named on this Form 483, for the inspection of Jun 20, 2011 – Jun 23, 2016. Each investigator has a profile showing what they cite most.
When was MSN Laboratories Private Limited inspected by FDA?
The inspection ran Jun 20, 2011 – Jun 23, 2016, and the Form 483 is dated June 23, 2016.
How do I get the full Form 483 for MSN Laboratories 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.