Johns Hopkins Fertility Center
Form 483 issued August 14, 2025
- Inspection
- Aug 12 – Aug 14, 2025
- Observations
- 2
- Pages
- 4
- FEI number
- 3003610950
In short: On August 14, 2025, FDA issued a Form 483 with 2 observations to Johns Hopkins Fertility Center (FEI 3003610950) after an inspection that ran Aug 12 – Aug 14, 2025. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.75 (how do I screen a donor?).
At a glance
2 of 2 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.75 (1×) · 1271.55 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Donors were not screened by a review of relevant medical records for risk factors and clinical…
- 02
The summary of records for HCT/Ps did not contain the address of the establishment that…
This inspection in context
Questions about this 483
What did FDA find at Johns Hopkins Fertility Center?
FDA listed 2 observations on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.75 (how do I screen a donor?). The opening words of each observation are shown on this page.
When was Johns Hopkins Fertility Center inspected by FDA?
The inspection ran Aug 12 – Aug 14, 2025, and the Form 483 is dated August 14, 2025.
How do I get the full Form 483 for Johns Hopkins Fertility 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.