Viatris Pharmaceuticals LLC
Form 483 issued December 20, 2019 · Barceloneta, Puerto Rico
- Inspection
- Dec 10 – Dec 20, 2019
- Investigator
- Noreen Muniz
- Observations
- 3
- Pages
- 4
- FEI number
- 2627208
In short: On December 20, 2019, FDA issued a Form 483 with 3 observations to Viatris Pharmaceuticals LLC in Barceloneta, Puerto Rico (FEI 2627208) after an inspection that ran Dec 10 – Dec 20, 2019. The investigator was Noreen Muniz. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 3 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Corrective and/or preventive actions implemented on site for manufacturing events (non-planned deviations) investigated as described in…
- 03
Batch production and control records do not include complete information relating to the production and…
This inspection in context
Noreen Muniz
24 documents · 2008–2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmViatris Pharmaceuticals LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Viatris Pharmaceuticals LLC?
FDA listed 3 observations on this Form 483, mostly about quality system and production. 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 Viatris Pharmaceuticals LLC?
Noreen Muniz is named on this Form 483, for the inspection of Dec 10 – Dec 20, 2019. Each investigator has a profile showing what they cite most.
When was Viatris Pharmaceuticals LLC inspected by FDA?
The inspection ran Dec 10 – Dec 20, 2019, and the Form 483 is dated December 20, 2019.
How do I get the full Form 483 for Viatris Pharmaceuticals LLC?
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.