Phoenix Diagnostics, Inc
Form 483 issued March 17, 2022 · Natick, Massachusetts
- Inspection
- Mar 15 – Mar 17, 2022
- Investigator
- James P. Finn
- Observations
- 4
- Pages
- 4
- FEI number
- 1222035
In short: On March 17, 2022, FDA issued a Form 483 with 4 observations to Phoenix Diagnostics, Inc in Natick, Massachusetts (FEI 1222035) after an inspection that ran Mar 15 – Mar 17, 2022. The investigator was James P. Finn. Most observations concern cAPA and management controls.
At a glance
CAPA and management controls account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for collective and preventive action have…
- 02
Procedures for training and identifying training needs have…
- 03
Procedures have not been adequately established to control product that does not…
- 04
Procedures for quality audits have…
This inspection in context
James P. Finn
10 documents · 2019–2026
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Massachusetts.
The firmPhoenix Diagnostics, 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 Phoenix Diagnostics, Inc?
FDA listed 4 observations on this Form 483, mostly about cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Phoenix Diagnostics, Inc?
James P. Finn is named on this Form 483, for the inspection of Mar 15 – Mar 17, 2022. Each investigator has a profile showing what they cite most.
When was Phoenix Diagnostics, Inc inspected by FDA?
The inspection ran Mar 15 – Mar 17, 2022, and the Form 483 is dated March 17, 2022.
How do I get the full Form 483 for Phoenix Diagnostics, 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.