Vero Biotech Inc.
Form 483 issued October 24, 2019 · Atlanta, Georgia
- Observations
- 2
- Pages
- 2
- FEI number
- 3014617112
In short: On October 24, 2019, FDA issued a Form 483 with 2 observations to Vero Biotech Inc. in Atlanta, Georgia (FEI 3014617112). Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.22 (1×) · 211.100 (1×)
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…
- 02
Deviations from written production and process control…
This inspection in context
Questions about this 483
What did FDA find at Vero Biotech Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system 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 Vero Biotech Inc. inspected by FDA?
This Form 483 is dated October 24, 2019.
How do I get the full Form 483 for Vero Biotech 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.