Tanvex BioPharma USA, Inc
Form 483 issued May 4, 2022 · San Diego, California
- Inspection
- Apr 25 – May 4, 2022
- Observations
- 8
- Pages
- 10
- FEI number
- 3013021112
In short: On May 4, 2022, FDA issued a Form 483 with 8 observations to Tanvex BioPharma USA, Inc in San Diego, California (FEI 3013021112) after an inspection that ran Apr 25 – May 4, 2022. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 6 of 8 observations.
Most cited: 21 CFR 211.22 (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
Responsibilities of the Quality Unit are not in…
- 02
Specifically, Quality control tests are not adequately qualified to assure samples conform to specification. me a…
- 03
Written procedures lack detailed…
- 04
Control of classified areas is inadequate…
This inspection in context
Questions about this 483
What did FDA find at Tanvex BioPharma USA, Inc?
FDA listed 8 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
When was Tanvex BioPharma USA, Inc inspected by FDA?
The inspection ran Apr 25 – May 4, 2022, and the Form 483 is dated May 4, 2022.
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.