Capricor, Inc.
FDA inspection history across 2 sites, 2025
- 2
- Form 483s
Every document, by year
- Form 483
2025: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2025Two Form 483s, at California and San Diego, California.
- 2025The longest 483 on file: 5 observations over 3 pages at California.
Cited most
Across all Capricor observations on file
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.198Complaint files2
- 21 CFR 211.58Maintenance2
The complete Capricor 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
California
One Form 483 · 2025 · 5 observations
Latest: Form 483, May 30, 2025 →San Diego, California
One Form 483 · 2025 · 5 observations
Latest: Form 483, May 30, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-05-30 | 483 Form 483 | California | 5 | $99 |
| 2025-05-30 | 483 Form 483 | San Diego, California | 5 | $99 |
Investigators on these documents
FEI number 3021247180 · most recent document May 30, 2025
About Capricor, Inc.
How many FDA Form 483s has Capricor, Inc. received?
FDA Intel has 2 Form 483s on file for Capricor, Inc.; the most recent is dated May 30, 2025.
When was Capricor, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Capricor, Inc. is a Form 483 dated May 30, 2025, for the site in California.
What did FDA cite at Capricor, Inc.?
The regulations cited most in the observations on file for Capricor, Inc. are 21 CFR 211.22 (Responsibilities of quality control unit), 4 times; 21 CFR 211.198 (Complaint files), 2 times; 21 CFR 211.58 (Maintenance), 2 times.