Auxogyn Inc. DBA Progyny, Inc
Form 483 issued June 1, 2016 · Menlo Park, California
- Inspection
- May 19 – Jun 1, 2016
- Investigator
- Kenneth Boehnen
- Observations
- 1
- Pages
- 2
- FEI number
- 3009716149
In short: On June 1, 2016, FDA issued a Form 483 with 1 observation to Auxogyn Inc. DBA Progyny, Inc in Menlo Park, California (FEI 3009716149) after an inspection that ran May 19 – Jun 1, 2016. The investigator was Kenneth Boehnen. 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(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Corrective and preventive action activities and/or results have…
This inspection in context
Kenneth Boehnen
2 documents · 2009–2016
Cites 820.100(b) (corrective and preventive action) more than any other section. Most of their documents are for sites in Arizona.
The firmAuxogyn Inc. DBA Progyny, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Auxogyn Inc. DBA Progyny, 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 Auxogyn Inc. DBA Progyny, Inc?
Kenneth Boehnen is named on this Form 483, for the inspection of May 19 – Jun 1, 2016. Each investigator has a profile showing what they cite most.
When was Auxogyn Inc. DBA Progyny, Inc inspected by FDA?
The inspection ran May 19 – Jun 1, 2016, and the Form 483 is dated June 1, 2016.
How do I get the full Form 483 for Auxogyn Inc. DBA Progyny, 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.