AS Software, Inc
Form 483 issued August 16, 2018 · Englewood Cliffs, New Jersey
- Inspection
- Jul 23 – Aug 16, 2018
- Investigator
- Li Li
- Observations
- 1
- Pages
- 4
- FEI number
- 3005207094
In short: On August 16, 2018, FDA issued a Form 483 with 1 observation to AS Software, Inc in Englewood Cliffs, New Jersey (FEI 3005207094) after an inspection that ran Jul 23 – Aug 16, 2018. The investigator was Li Li. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action…
This inspection in context
Li Li
4 documents · 2015–2018
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in New Jersey.
The firmAS Software, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AS Software, Inc?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected AS Software, Inc?
Li Li is named on this Form 483, for the inspection of Jul 23 – Aug 16, 2018. Each investigator has a profile showing what they cite most.
When was AS Software, Inc inspected by FDA?
The inspection ran Jul 23 – Aug 16, 2018, and the Form 483 is dated August 16, 2018.
How do I get the full Form 483 for AS Software, 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.