# FDA 483 - Zoila M. Alen, M.D. - February 09, 2024

Source: https://www.keypedia.com/records/483/zoila-m-alen-md/d4996ad8-166a-43e0-9d05-efbf81836543

> FDA 483 for Zoila M. Alen, M.D. on February 09, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zoila M. Alen, M.D.
- Inspection Date: 2024-02-09
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Zoila M. Alen, MD, Clinical Investigator, was cited for significant deficiencies during an FDA inspection regarding the conduct of clinical studies. The inspection revealed failures to adhere to investigational plans, including enrolling subjects who did not meet inclusion criteria and improper dosing. Additionally, the firm failed to maintain accurate case histories, with issues such as unconfirmed data changes, duplicate source documents, and discrepancies in GCP training certificates.

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Company: https://www.keypedia.com/companies/zoila-m-alen-md/1edccd55-094e-4c92-8f89-e8b007972307

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6