Capricor, Inc.
Form 483 issued May 30, 2025 · California
- Inspection
- May 27 – May 30, 2025
- Investigators
- Carl Perez· Ivey Choi· Kyung Sung
- Observations
- 5
- Pages
- 3
- FEI number
- 3021247180
In short: On May 30, 2025, FDA issued a Form 483 with 5 observations to Capricor, Inc. in California (FEI 3021247180) after an inspection that ran May 27 – May 30, 2025. The investigators were Carl Perez, Ivey Choi and Kyung Sung. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
3 of 5 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(b)(4) in the lacks…
- 02
Written procedures are not…
- 03
Quality agreements are not established between…
- 04
Procedures applicable to the…
This inspection in context
Carl Perez
7 documents · 2022–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
The firmCapricor, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Capricor, Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Capricor, Inc.?
Carl Perez, Ivey Choi and Kyung Sung are named on this Form 483, for the inspection of May 27 – May 30, 2025. Each investigator has a profile showing what they cite most.
When was Capricor, Inc. inspected by FDA?
The inspection ran May 27 – May 30, 2025, and the Form 483 is dated May 30, 2025.
How do I get the full Form 483 for Capricor, 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.