MSN Life Sciences Private Limited
Form 483 issued June 30, 2017 · Medak, India
- Inspection
- Jun 26 – Jun 30, 2017
- Investigators
- Lata Mathew· Stacie Woods
- Observations
- 2
- Pages
- 1
- FEI number
- 3011543392
In short: On June 30, 2017, FDA issued a Form 483 with 2 observations to MSN Life Sciences Private Limited in Medak, Telangana (FEI 3011543392) after an inspection that ran Jun 26 – Jun 30, 2017. The investigators were Lata Mathew and Stacie Woods. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include appropriate standards designed to assure that API and raw materials conform…
- 02
Established laboratory control mechanisms…
This inspection in context
Lata Mathew
24 documents · 2017–2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.160
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 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected MSN Life Sciences Private Limited?
Lata Mathew and Stacie Woods are named on this Form 483, for the inspection of Jun 26 – Jun 30, 2017. Each investigator has a profile showing what they cite most.
When was MSN Life Sciences Private Limited inspected by FDA?
The inspection ran Jun 26 – Jun 30, 2017, and the Form 483 is dated June 30, 2017.
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.