Patrin Pharma, Inc
Form 483 issued October 18, 2022 · Niles, Illinois
- Inspection
- Oct 11 – Oct 18, 2022
- Investigator
- Nicholas Z. Lu
- Observations
- 3
- Pages
- 7
- FEI number
- 3006557630
In short: On October 18, 2022, FDA issued a Form 483 with 3 observations to Patrin Pharma, Inc in Niles, Illinois (FEI 3006557630) after an inspection that ran Oct 11 – Oct 18, 2022. The investigator was Nicholas Z. Lu. Most observations concern cAPA and design controls.
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design control…
- 02
Procedures for corrective and preventive action have not been adequately established. Procedures for corrective and preventive…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Nicholas Z. Lu
10 documents · 2018–2024
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Illinois.
The firmPatrin Pharma, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Patrin Pharma, Inc?
FDA listed 3 observations on this Form 483, mostly about cAPA and design controls. The opening words of each observation are shown on this page.
Who inspected Patrin Pharma, Inc?
Nicholas Z. Lu is named on this Form 483, for the inspection of Oct 11 – Oct 18, 2022. Each investigator has a profile showing what they cite most.
When was Patrin Pharma, Inc inspected by FDA?
The inspection ran Oct 11 – Oct 18, 2022, and the Form 483 is dated October 18, 2022.
How do I get the full Form 483 for Patrin Pharma, 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.