Arstasis, Inc
Form 483 issued April 9, 2015 · Fremont, California
- Inspection
- Mar 26 – Apr 9, 2015
- Investigator
- Jude C. Dike
- Observations
- 1
- Pages
- 2
- FEI number
- 3008493244
In short: On April 9, 2015, FDA issued a Form 483 with 1 observation to Arstasis, Inc in Fremont, California (FEI 3008493244) after an inspection that ran Mar 26 – Apr 9, 2015. The investigator was Jude C. Dike. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.198(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Complaints representing events that are MDR reportable were not maintained in a separate portion of the…
This inspection in context
Jude C. Dike
9 documents · 2015–2022
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Maryland.
The firmArstasis, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Arstasis, Inc?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Arstasis, Inc?
Jude C. Dike is named on this Form 483, for the inspection of Mar 26 – Apr 9, 2015. Each investigator has a profile showing what they cite most.
When was Arstasis, Inc inspected by FDA?
The inspection ran Mar 26 – Apr 9, 2015, and the Form 483 is dated April 9, 2015.
How do I get the full Form 483 for Arstasis, 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.