Viatris Pharmaceuticals LLC
Form 483 issued July 2, 2015 · Barceloneta, Puerto Rico
- Inspection
- Jun 22 – Jul 2, 2015
- Investigators
- Jose A. Cruz-Gonzalez· Moraima J. Ramos-Valle· Samina S. Khan
- Observations
- 4
- Pages
- 3
- FEI number
- 2627208
In short: On July 2, 2015, FDA issued a Form 483 with 4 observations to Viatris Pharmaceuticals LLC in Barceloneta, Puerto Rico (FEI 2627208) after an inspection that ran Jun 22 – Jul 2, 2015. The investigators were Jose A. Cruz-Gonzalez, Moraima J. Ramos-Valle and Samina S. Khan. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Routine calibration of automatic and mechanical equipment is not performed according to a written program designed…
- 03
Established laboratory control mechanisms…
- 04
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
This inspection in context
Jose A. Cruz-Gonzalez
11 documents · 2013–2019
Cites 211.113 (control of microbiological contamination) 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 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Viatris Pharmaceuticals LLC?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. 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 Pharmaceuticals LLC?
Jose A. Cruz-Gonzalez, Moraima J. Ramos-Valle and Samina S. Khan are named on this Form 483, for the inspection of Jun 22 – Jul 2, 2015. Each investigator has a profile showing what they cite most.
When was Viatris Pharmaceuticals LLC inspected by FDA?
The inspection ran Jun 22 – Jul 2, 2015, and the Form 483 is dated July 2, 2015.
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.