Davion Inc
Form 483 issued May 15, 2019 · Newark, New Jersey
- Inspection
- May 15, 2019
- Observations
- 3
- Pages
- 3
- FEI number
- 2245909
In short: On May 15, 2019, FDA issued a Form 483 with 3 observations to Davion Inc in Newark, New Jersey (FEI 2245909) after an inspection that ran May 15, 2019. Most observations concern facilities & equipment and quality system.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
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
Written procedures are not followed for the cleaning and maintenance of equipment, used in manufacture, processing…
- 03
Equipment for adequate control over humidity and temperature is not provided when appropriate for the manufacture…
This inspection in context
Questions about this 483
What did FDA find at Davion Inc?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
When was Davion Inc inspected by FDA?
The inspection ran May 15, 2019, and the Form 483 is dated May 15, 2019.
How do I get the full Form 483 for Davion 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.