Tanvex BioPharma USA, Inc
Form 483 issued May 2, 2019 · San Diego, California
- Inspection
- Apr 23 – May 2, 2019
- Investigators
- Aeicige Ia· Be Diane Raceasi
- Observations
- 20
- Pages
- 10
- FEI number
- 3013021112
In short: On May 2, 2019, FDA issued a Form 483 with 20 observations to Tanvex BioPharma USA, Inc in San Diego, California (FEI 3013021112) after an inspection that ran Apr 23 – May 2, 2019. The investigators were Aeicige Ia and Be Diane Raceasi. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.42 (3×) · 211.160 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Procedures designed to prevent microbial contamination of drug products purporting to be sterile do not include…
- 03
Your examination and testing of samples did not assure that the drug product and in-process…
- 04
Aseptic processing areas are deficient regarding systems for maintaining equipment used to…
This inspection in context
Aeicige Ia
1 document · 2019
Cites 211.160 (general requirements) 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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tanvex BioPharma USA, Inc?
FDA listed 20 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Tanvex BioPharma USA, Inc?
Aeicige Ia and Be Diane Raceasi are named on this Form 483, for the inspection of Apr 23 – May 2, 2019. Each investigator has a profile showing what they cite most.
When was Tanvex BioPharma USA, Inc inspected by FDA?
The inspection ran Apr 23 – May 2, 2019, and the Form 483 is dated May 2, 2019.
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.