Loyola Univ Medical Center
Form 483 issued December 5, 2024
- Inspection
- Dec 2 – Dec 5, 2024
- Observations
- 2
- Pages
- 3
- FEI number
- 1475369
In short: On December 5, 2024, FDA issued a Form 483 with 2 observations to Loyola Univ Medical Center (FEI 1475369) after an inspection that ran Dec 2 – Dec 5, 2024. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 600.12 (records).
At a glance
2 of 2 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 600.12(a) (1×) · 606.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Records are not made concurrently with the performance of each step in…
- 02
Written standard operating procedures including all steps to be followed in the processing of blood and…
This inspection in context
Questions about this 483
What did FDA find at Loyola Univ Medical Center?
FDA listed 2 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 600.12 (records). The opening words of each observation are shown on this page.
When was Loyola Univ Medical Center inspected by FDA?
The inspection ran Dec 2 – Dec 5, 2024, and the Form 483 is dated December 5, 2024.
How do I get the full Form 483 for Loyola Univ Medical Center?
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.