Ossium Health, Inc.
Form 483 issued May 30, 2024 · Indianapolis, Indiana
- Inspection
- May 20 – May 30, 2024
- Investigator
- Lesley Mae P. Lutao
- Observations
- 2
- Pages
- 3
- FEI number
- 3018425658
In short: On May 30, 2024, FDA issued a Form 483 with 2 observations to Ossium Health, Inc. in Indianapolis, Indiana (FEI 3018425658) after an inspection that ran May 20 – May 30, 2024. The investigator was Lesley Mae P. Lutao. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.220 (processing and process controls).
At a glance
2 of 2 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.220(c) (1×) · 1271.270(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Specified requirements for in-process…
- 02
Records were not maintained concurrently with the…
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 firmOssium Health, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.220(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ossium Health, Inc.?
FDA listed 2 observations on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.220 (processing and process controls). The opening words of each observation are shown on this page.
Who inspected Ossium Health, Inc.?
Lesley Mae P. Lutao is named on this Form 483, for the inspection of May 20 – May 30, 2024. Each investigator has a profile showing what they cite most.
When was Ossium Health, Inc. inspected by FDA?
The inspection ran May 20 – May 30, 2024, and the Form 483 is dated May 30, 2024.
How do I get the full Form 483 for Ossium Health, 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.