Paradox Inc
Form 483 issued October 11, 2024 · Saint Joseph, Missouri
- Inspection
- Oct 7 – Oct 11, 2024
- Investigators
- Conner N. Mann· Eric D. Bowles
- Observations
- 4
- Pages
- 4
- FEI number
- 1927976
In short: On October 11, 2024, FDA issued a Form 483 with 4 observations to Paradox Inc in Saint Joseph, Missouri (FEI 1927976) after an inspection that ran Oct 7 – Oct 11, 2024. The investigators were Conner N. Mann and Eric D. Bowles. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Failure to maintain a backup file of data entered into the…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Buildings used in the holding of a drug product are not maintained in a…
This inspection in context
Conner N. Mann
7 documents · 2023–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Kansas.
The firmParadox Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Paradox Inc?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Paradox Inc?
Conner N. Mann and Eric D. Bowles are named on this Form 483, for the inspection of Oct 7 – Oct 11, 2024. Each investigator has a profile showing what they cite most.
When was Paradox Inc inspected by FDA?
The inspection ran Oct 7 – Oct 11, 2024, and the Form 483 is dated October 11, 2024.
How do I get the full Form 483 for Paradox 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.