Oxus, Inc
Form 483 issued October 10, 2019 · Auburn Hills, Michigan
- Inspection
- Oct 9 – Oct 10, 2019
- Investigator
- Thomas A. Peter
- Observations
- 2
- Pages
- 5
- FEI number
- 3008841036
In short: On October 10, 2019, FDA issued a Form 483 with 2 observations to Oxus, Inc in Auburn Hills, Michigan (FEI 3008841036) after an inspection that ran Oct 9 – Oct 10, 2019. The investigator was Thomas A. Peter. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
2 of 2 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for collective and preventive action have…
- 0221 CFR 820.198(a)21 CFR 820
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Thomas A. Peter
9 documents · 2011–2019
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in Indiana.
The firmOxus, 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 Oxus, Inc?
FDA listed 2 observations 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 Oxus, Inc?
Thomas A. Peter is named on this Form 483, for the inspection of Oct 9 – Oct 10, 2019. Each investigator has a profile showing what they cite most.
When was Oxus, Inc inspected by FDA?
The inspection ran Oct 9 – Oct 10, 2019, and the Form 483 is dated October 10, 2019.
How do I get the full Form 483 for Oxus, 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.