Rivopharm SA
Form 483 issued January 18, 2019 · MANNO, Switzerland
- Inspection
- Jan 14 – Jan 18, 2019
- Investigator
- Joey V. Quitania
- Observations
- 1
- Pages
- 1
- FEI number
- 3005884589
In short: On January 18, 2019, FDA issued a Form 483 with 1 observation to Rivopharm SA in MANNO, TI (FEI 3005884589) after an inspection that ran Jan 14 – Jan 18, 2019. The investigator was Joey V. Quitania. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Changes to written procedures are not reviewed and approved by…
This inspection in context
Joey V. Quitania
23 documents · 2009–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmRivopharm SA history
The site's inspection history, in date order.
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 Rivopharm SA?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Rivopharm SA?
Joey V. Quitania is named on this Form 483, for the inspection of Jan 14 – Jan 18, 2019. Each investigator has a profile showing what they cite most.
When was Rivopharm SA inspected by FDA?
The inspection ran Jan 14 – Jan 18, 2019, and the Form 483 is dated January 18, 2019.
How do I get the full Form 483 for Rivopharm SA?
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.