# FDA 483 - IDO PHARM - November 10, 2025

Source: https://www.keypedia.com/records/483/ido-pharm/0fd84c59-24ac-42d5-9528-09ca3bc24b9e

> FDA 483 for IDO PHARM on November 10, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: IDO PHARM
- Inspection Date: 2025-11-10
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: IDO Pharm, an OTC drug manufacturer in Ansan-si, Gyeonggi-do, Republic of Korea, was cited for significant deficiencies across its quality systems. The inspection revealed widespread issues including unvalidated laboratory methods, inadequate equipment cleaning and maintenance, lack of process and environmental monitoring, and incomplete batch records. These conditions indicate a severe lack of control over critical manufacturing and testing processes, posing risks to drug product quality and patient safety.

## Related Documents

- [WARNING_LETTER - 2025-11-13](https://www.keypedia.com/records/warning_letter/ido-pharm/0f6ec5b6-1389-4a82-bfd2-d7988ed341d9)

## Related Officers

- [Dennis Cantellops Paite](https://www.keypedia.com/people/dennis-cantellops-paite/3336bbb8-8520-4a8a-9085-76e7a55ca773)

Company: https://www.keypedia.com/companies/ido-pharm/f9c98a5c-4dc5-424d-98ab-461778ae3ea9

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1