VIVA PHARMACEUTICAL INC.
Form 483 issued October 25, 2024 · Richmond, Canada
- Inspection
- Oct 21 – Oct 25, 2024
- Investigator
- Arsen Karapetyan
- Observations
- 4
- Pages
- 3
- FEI number
- 3002704547
In short: On October 25, 2024, FDA issued a Form 483 with 4 observations to VIVA PHARMACEUTICAL INC. in Richmond, British Columbia (FEI 3002704547) after an inspection that ran Oct 21 – Oct 25, 2024. The investigator was Arsen Karapetyan. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 02
The responsibilities and procedures applicable to the quality control unit are not in writing and fully…
- 03
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 04
Buildings used in the manufacturing of a drug product are not maintained in a…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmVIVA PHARMACEUTICAL INC. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at VIVA PHARMACEUTICAL INC.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected VIVA PHARMACEUTICAL INC.?
Arsen Karapetyan is named on this Form 483, for the inspection of Oct 21 – Oct 25, 2024. Each investigator has a profile showing what they cite most.
When was VIVA PHARMACEUTICAL INC. inspected by FDA?
The inspection ran Oct 21 – Oct 25, 2024, and the Form 483 is dated October 25, 2024.
How do I get the full Form 483 for VIVA PHARMACEUTICAL 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.