IsoTis OrthoBiologics, Inc. 2 Goodyear Ste A
FDA inspection history in Irvine, California, 2026
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2026: one Form 483 and one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2026One Form 483 and one warning letter, at Irvine, California.
Cited most
Across all IsoTis OrthoBiologics, Inc. 2 Goodyear Ste A observations on file
- 21 CFR 1271.10Are 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?1
- 21 CFR 1271.290Tracking1
The complete IsoTis OrthoBiologics, Inc. 2 Goodyear Ste A file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Irvine, California
One Form 483 and one warning letter · 2026 · 2 observations
Latest: Form 483, Mar 6, 2026 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-03-06 | 483 Form 483 | Irvine, California | 2 | $99 |
| 2026-02-24 | Warning letter Warning letter | Irvine, California | — | $99 |
Investigators on these documents
FEI number 3001503333 · most recent document Mar 6, 2026
About IsoTis OrthoBiologics, Inc. 2 Goodyear Ste A
How many FDA Form 483s has IsoTis OrthoBiologics, Inc. 2 Goodyear Ste A received?
FDA Intel has 1 Form 483 on file for IsoTis OrthoBiologics, Inc. 2 Goodyear Ste A; the most recent is dated Mar 6, 2026.
When was IsoTis OrthoBiologics, Inc. 2 Goodyear Ste A last inspected by FDA?
The most recent FDA inspection document on file for IsoTis OrthoBiologics, Inc. 2 Goodyear Ste A is a Form 483 dated Mar 6, 2026, for the site in Irvine, California.
What did FDA cite at IsoTis OrthoBiologics, Inc. 2 Goodyear Ste A?
The regulations cited most in the observations on file for IsoTis OrthoBiologics, Inc. 2 Goodyear Ste A are 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?), 1 time; 21 CFR 1271.290 (Tracking), 1 time.
Has IsoTis OrthoBiologics, Inc. 2 Goodyear Ste A received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for IsoTis OrthoBiologics, Inc. 2 Goodyear Ste A; the most recent is dated Feb 24, 2026.