Boston IVF Fertility Services at The
Form 483 issued September 9, 2025 · Newburgh, Indiana
- Inspection
- Sep 8 – Sep 9, 2025
- Investigator
- Lesley Mae P. Lutao
- Observations
- 2
- Pages
- 4
- FEI number
- 3010149285
In short: On September 9, 2025, FDA issued a Form 483 with 2 observations to Boston IVF Fertility Services at The in Newburgh, Indiana (FEI 3010149285) after an inspection that ran Sep 8 – Sep 9, 2025. The investigator was Lesley Mae P. Lutao. 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(a)(1) (1×) · 1271.47(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Donors were not screened by a review of relevant medical records for risk factors of communicable…
- 02
You did not establish and maintain procedures for…
This inspection in context
Lesley Mae P. Lutao
4 documents · 2024–2026
Cites 1271.220(c) (processing and process controls) more than any other section. Most of their documents are for sites in Indiana.
The firmBoston IVF Fertility Services at The history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.75(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Boston IVF Fertility Services at The?
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.
Who inspected Boston IVF Fertility Services at The?
Lesley Mae P. Lutao is named on this Form 483, for the inspection of Sep 8 – Sep 9, 2025. Each investigator has a profile showing what they cite most.
When was Boston IVF Fertility Services at The inspected by FDA?
The inspection ran Sep 8 – Sep 9, 2025, and the Form 483 is dated September 9, 2025.
How do I get the full Form 483 for Boston IVF Fertility Services at The?
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.