Capricor, Inc.
Form 483 issued May 30, 2025 · San Diego, California
- Inspection
- May 27 – May 30, 2025
- 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 San Diego, California (FEI 3021247180) after an inspection that ran May 27 – May 30, 2025. 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
Quality system and facilities & equipment account for 3 of 5 observations.
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 (b)…
- 02
Written procedures are not…
- 03
Quality agreements are not established between (b) (4) facilities and (b) (4) to delineate the roles…
- 04
Procedures applicable to the quality control unit…
This inspection in context
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.
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.