# FDA 483 - Jose C. Pinero, M.D. - October 09, 2025

Source: https://www.globalkeysolutions.net/records/483/jose-c-pinero-md/a453e4a5-fe5b-4eb8-a9af-9e2bc10669d1

> FDA 483 for Jose C. Pinero, M.D. on October 09, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jose C. Pinero, M.D.
- Inspection Date: 2025-10-09
- Product Type: drugs
- Office Name: Florida District Office
- Summary: An FDA inspection of Jose C. Pinero, M.D., a clinical investigator in Coral Gables, FL, revealed significant deficiencies in the conduct of a clinical investigation. Observations included a failure to adhere to the investigational plan regarding participant randomization and consent timing, as well as a failure to maintain adequate and accurate case histories, lacking original and contemporaneous records for participant consent and symptom documentation.

## Related Officers

- [Richard A. Lyght](https://www.globalkeysolutions.net/people/richard-a-lyght/8d60b5c0-4acd-4abc-979a-fb4b3e82964d)

Company: https://www.globalkeysolutions.net/companies/jose-c-pinero-md/9c5d4ff7-7aad-4e67-b162-ec8f5610f9a6

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9