# FDA 483 - COSMAX, INC. - October 18, 2024

Source: https://www.globalkeysolutions.net/records/483/cosmax-inc/71e1498b-6bf2-43d6-91fb-706512838230

> FDA 483 for COSMAX, INC. on October 18, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: COSMAX, INC.
- Inspection Date: 2024-10-18
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: During an inspection, COSMAX, INC., a pharmaceutical manufacturer in Hwaseong-si, Gyeonggi-do, Korea, was cited for significant deficiencies in its investigation procedures. The firm's written records for out-of-specification chemistry results and supplier nonconformances consistently failed to include complete root cause evaluations and adequate follow-up actions to prevent reoccurrence. This indicates a systemic issue with their quality control and corrective action processes.

## Related Officers

- [ Investigator ](https://www.globalkeysolutions.net/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

Company: https://www.globalkeysolutions.net/companies/cosmax-inc/c43facbb-da86-40d8-8a34-caa7c1b2d17c

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8