MSN Laboratories PRIVATE LIMITED
Form 483 issued March 8, 2019 · NANDIGAMA, India
- Inspection
- Mar 8, 2019
- Investigator
- Guerlain Ulysse
- Observations
- 1
- Pages
- 2
- FEI number
- 3011033544
In short: On March 8, 2019, FDA issued a Form 483 with 1 observation to MSN Laboratories PRIVATE LIMITED in NANDIGAMA, Telangana (FEI 3011033544) after an inspection that ran Mar 8, 2019. The investigator was Guerlain Ulysse. Most observations concern production; the most-cited regulation is 21 CFR 211.111 (time limitations on production).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.111 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Time limits and (©)(@Y PP} for production equipment are not established when appropriate for the completion…
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 firmMSN Laboratories 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 211.111
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MSN Laboratories PRIVATE LIMITED?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.111 (time limitations on production). The opening words of each observation are shown on this page.
Who inspected MSN Laboratories PRIVATE LIMITED?
Guerlain Ulysse is named on this Form 483, for the inspection of Mar 8, 2019. Each investigator has a profile showing what they cite most.
When was MSN Laboratories PRIVATE LIMITED inspected by FDA?
The inspection ran Mar 8, 2019, and the Form 483 is dated March 8, 2019.
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.