# FDA 483 - Capricor, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/capricor-inc/abc425b0-aa5d-413e-8813-a61fc7829fe6

> FDA 483 for Capricor, Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Capricor, Inc.
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Capricor, Inc. in San Diego, CA, a drug substance and drug product manufacturer, was cited for multiple deficiencies during an FDA inspection from May 27-30, 2025. Observations included inadequate qualification of equipment, failure to follow written procedures for quality management and documentation, and a lack of quality agreements with external facilities. Additionally, the facility's quality control unit lacked written procedures, and equipment was not maintained in a good state of repair.

## Related Documents

- [CRL - Unknown Date](https://www.keypedia.com/records/crl/capricor-inc/bf192b56-c066-4adf-ab8f-6d326c785a2a)

## Related Officers

- [Kyung E. Sung](https://www.keypedia.com/people/kyung-e-sung/33e174fb-758f-43ea-bf63-24688f52ddc0)
- [Malcolm C. Moos](https://www.keypedia.com/people/malcolm-c-moos/44864fd6-9588-4b30-aaf7-26be3cdf10fa)
- [Carl Petez](https://www.keypedia.com/people/carl-petez/b1e59c1d-d402-4902-98e1-405f86c08b45)
- [Kyung Choi](https://www.keypedia.com/people/kyung-choi/ff45eab2-508a-4497-9bbe-4f7b2e07f1d7)

Company: https://www.keypedia.com/companies/capricor-inc/6cf77d9e-08a4-4eca-9918-7f060000bc2a

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd