MSN Life Sciences Private Limited
Form 483 issued June 3, 2022 · Bhiknoor (Village), India
- Inspection
- May 30 – Jun 3, 2022
- Investigator
- Lata Mathew
- Observations
- 3
- Pages
- 3
- FEI number
- 3014775167
In short: On June 3, 2022, FDA issued a Form 483 with 3 observations to MSN Life Sciences Private Limited in Bhiknoor (Village), Telangana (FEI 3014775167) after an inspection that ran May 30 – Jun 3, 2022. The investigator was Lata Mathew. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Review of audit trail for analytical data generated by…
- 02
Failure to ensure that all sampling plans are scientifically sound and appropriate to ensure that your…
- 03
Methods are not validated…
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
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 Life Sciences Private Limited?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and 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?
Lata Mathew is named on this Form 483, for the inspection of May 30 – Jun 3, 2022. Each investigator has a profile showing what they cite most.
When was MSN Life Sciences Private Limited inspected by FDA?
The inspection ran May 30 – Jun 3, 2022, and the Form 483 is dated June 3, 2022.
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.