VIVA PHARMACEUTICAL INC.
Form 483 issued January 10, 2020 · Richmond, Canada
- Inspection
- Jan 6 – Jan 10, 2020
- Investigator
- Ucheabuchi C. Chudi-Nwankwor
- Observations
- 14
- Pages
- 6
- FEI number
- 3002704547
In short: On January 10, 2020, FDA issued a Form 483 with 14 observations to VIVA PHARMACEUTICAL INC. in Richmond, British Columbia (FEI 3002704547) after an inspection that ran Jan 6 – Jan 10, 2020. The investigator was Ucheabuchi C. Chudi-Nwankwor. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and production account for 9 of 14 observations.
What FDA observed
Preview: the opening words of each observation- 01
The suitability of all testing methods is not verified under…
- 02
Complete records are not maintained of any modification of an established…
- 03
Results of stability testing are not used…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Ucheabuchi C. Chudi-Nwankwor
22 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Ohio.
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 211.194(a)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at VIVA PHARMACEUTICAL INC.?
FDA listed 14 observations on this Form 483, mostly about laboratory controls, production 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 VIVA PHARMACEUTICAL INC.?
Ucheabuchi C. Chudi-Nwankwor is named on this Form 483, for the inspection of Jan 6 – Jan 10, 2020. Each investigator has a profile showing what they cite most.
When was VIVA PHARMACEUTICAL INC. inspected by FDA?
The inspection ran Jan 6 – Jan 10, 2020, and the Form 483 is dated January 10, 2020.
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.