Tanvex BioPharma USA, Inc
Form 483 issued January 24, 2023 · San Diego, California
- Inspection
- Jan 17 – Jan 24, 2023
- Investigators
- Bryan A. Galvez· Ian L. McWilliams· Jun Liu
- Observations
- 3
- Pages
- 2
- FEI number
- 3013021112
In short: On January 24, 2023, FDA issued a Form 483 with 3 observations to Tanvex BioPharma USA, Inc in San Diego, California (FEI 3013021112) after an inspection that ran Jan 17 – Jan 24, 2023. The investigators were Bryan A. Galvez, Ian L. McWilliams, Jun Liu, Michael R. Shanks and Yi Wang. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
cGMP procedures and records are not…
- 02
Quality oversight of the facility and…
- 03
Facility and Equipment maintenance are deficient in their ability to…
This inspection in context
Bryan A. Galvez
15 documents · 2018–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmTanvex BioPharma USA, Inc 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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tanvex BioPharma USA, Inc?
FDA listed 3 observations on this Form 483, mostly about production, quality system and facilities & equipment. 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 Tanvex BioPharma USA, Inc?
Bryan A. Galvez, Ian L. McWilliams, Jun Liu, Michael R. Shanks and Yi Wang are named on this Form 483, for the inspection of Jan 17 – Jan 24, 2023. Each investigator has a profile showing what they cite most.
When was Tanvex BioPharma USA, Inc inspected by FDA?
The inspection ran Jan 17 – Jan 24, 2023, and the Form 483 is dated January 24, 2023.
How do I get the full Form 483 for Tanvex BioPharma USA, 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.