IsoTis OrthoBiologics, Inc. 2 Goodyear Ste A
Form 483 issued March 6, 2026 · Irvine, California
- Inspection
- Mar 2 – Mar 6, 2026
- Investigator
- Melsomar R. Ramos
- Observations
- 2
- Pages
- 3
- FEI number
- 3001503333
In short: On March 6, 2026, FDA issued a Form 483 with 2 observations to IsoTis OrthoBiologics, Inc. 2 Goodyear Ste A in Irvine, California (FEI 3001503333) after an inspection that ran Mar 2 – Mar 6, 2026. The investigator was Melsomar R. Ramos. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.10 (are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?).
At a glance
2 of 2 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.10 (1×) · 1271.290 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 1271.10
You did not ensure that establishment(s) that by contract, agreement or arrangement, perform manufacturing steps for…
- 02
Consignees were not informed in writing at or before the time of distribution of an HCT/P…
This inspection in context
Melsomar R. Ramos
2 documents · 2025–2026
Cites 1271.55(b)(1) (what records must accompany an hct/p after the donor-eligibility determination is complete; and what records must i retain?) more than any other section. Most of their documents are for sites in California.
The firmIsoTis OrthoBiologics, Inc. 2 Goodyear Ste A history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 1271.290
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at IsoTis OrthoBiologics, Inc. 2 Goodyear Ste A?
FDA listed 2 observations on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.10 (are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?). The opening words of each observation are shown on this page.
Who inspected IsoTis OrthoBiologics, Inc. 2 Goodyear Ste A?
Melsomar R. Ramos is named on this Form 483, for the inspection of Mar 2 – Mar 6, 2026. Each investigator has a profile showing what they cite most.
When was IsoTis OrthoBiologics, Inc. 2 Goodyear Ste A inspected by FDA?
The inspection ran Mar 2 – Mar 6, 2026, and the Form 483 is dated March 6, 2026.
How do I get the full Form 483 for IsoTis OrthoBiologics, Inc. 2 Goodyear Ste A?
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.