Viatris Pharmaceuticals LLC
Form 483 issued August 20, 2013 · Barceloneta, Puerto Rico
- Inspection
- Aug 5 – Aug 20, 2013
- Investigators
- Noreen Muniz· Raquel Gonzalez Rivera
- Observations
- 16
- Pages
- 15
- FEI number
- 2627208
In short: On August 20, 2013, FDA issued a Form 483 with 16 observations to Viatris Pharmaceuticals LLC in Barceloneta, Puerto Rico (FEI 2627208) after an inspection that ran Aug 5 – Aug 20, 2013. The investigators were Noreen Muniz and Raquel Gonzalez Rivera. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and quality system account for 11 of 16 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing the handling of written and oral complaints related to drug products are…
- 02
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 03
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
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 211.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Viatris Pharmaceuticals LLC?
FDA listed 16 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Viatris Pharmaceuticals LLC?
Noreen Muniz and Raquel Gonzalez Rivera are named on this Form 483, for the inspection of Aug 5 – Aug 20, 2013. Each investigator has a profile showing what they cite most.
When was Viatris Pharmaceuticals LLC inspected by FDA?
The inspection ran Aug 5 – Aug 20, 2013, and the Form 483 is dated August 20, 2013.
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.