Viatris, Inc.
Form 483 issued June 26, 2024 · Pithampur, District Dhar, India
- Inspection
- Jun 14 – Jun 26, 2024
- Investigators
- Pratik S. Upadhyay· Steven A. Brettler
- Observations
- 6
- Pages
- 18
- FEI number
- 3010453141
In short: On June 26, 2024, FDA issued a Form 483 with 6 observations to Viatris, Inc. in Pithampur, District Dhar, Madhya Pradesh (FEI 3010453141) after an inspection that ran Jun 14 – Jun 26, 2024. The investigators were Pratik S. Upadhyay and Steven A. Brettler. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent that would alter the safety…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Pratik S. Upadhyay
48 documents · 2011–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Viatris, Inc.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Viatris, Inc.?
Pratik S. Upadhyay and Steven A. Brettler are named on this Form 483, for the inspection of Jun 14 – Jun 26, 2024. Each investigator has a profile showing what they cite most.
When was Viatris, Inc. inspected by FDA?
The inspection ran Jun 14 – Jun 26, 2024, and the Form 483 is dated June 26, 2024.
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.