Viatris, Inc.
Form 483 issued February 5, 2016 · Pithampur, India
- Inspection
- Feb 1 – Feb 5, 2015
- Investigator
- Ariel Cruz Figueroa
- Observations
- 1
- Pages
- 1
- FEI number
- 3010453141
In short: On February 5, 2016, FDA issued a Form 483 with 1 observation to Viatris, Inc. in Pithampur, District Dhar (FEI 3010453141) after an inspection that ran Feb 1 – Feb 5, 2015. The investigator was Ariel Cruz Figueroa. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
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 the establishment of scientifically sound and appropriate sampling plans designed to…
This inspection in context
Ariel Cruz Figueroa
16 documents · 2015–2023
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmViatris, Inc. history
All 3 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 Viatris, Inc.?
FDA listed 1 observation 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 Viatris, Inc.?
Ariel Cruz Figueroa is named on this Form 483, for the inspection of Feb 1 – Feb 5, 2015. Each investigator has a profile showing what they cite most.
When was Viatris, Inc. inspected by FDA?
The inspection ran Feb 1 – Feb 5, 2015, and the Form 483 is dated February 5, 2016.
How do I get the full Form 483 for Viatris, Inc.?
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.