Johns Hopkins Hospital
Form 483 issued February 13, 2025 · Baltimore, Maryland
- Inspection
- Feb 10 – Feb 13, 2025
- Observations
- 2
- Pages
- 4
- FEI number
- 1171573
In short: On February 13, 2025, FDA issued a Form 483 with 2 observations to Johns Hopkins Hospital in Baltimore, Maryland (FEI 1171573) after an inspection that ran Feb 10 – Feb 13, 2025. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.151 (compatibility testing).
At a glance
2 of 2 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.151(e) (1×) · 606.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 0121 CFR 606.151(e)
Records including signature by the physician requesting the procedure are not maintained…
- 02
Written standard operating procedures including all steps to be followed in the compatibility testing and distribution…
This inspection in context
Questions about this 483
What did FDA find at Johns Hopkins Hospital?
FDA listed 2 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.151 (compatibility testing). The opening words of each observation are shown on this page.
When was Johns Hopkins Hospital inspected by FDA?
The inspection ran Feb 10 – Feb 13, 2025, and the Form 483 is dated February 13, 2025.
How do I get the full Form 483 for Johns Hopkins Hospital?
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.