# PENMIX LTD – FDA 483, May 29, 2026

Source: https://www.keypedia.com/records/483/penmix-ltd/30afb7c0-8689-4b1c-ac3a-6460e027c9dd

> FDA 483 for PENMIX LTD on May 29, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PENMIX LTD
- Inspection Date: 2026-05-29
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: PENMIX LTD, a sterile drug manufacturer in Cheonan, Korea, was cited for multiple significant deficiencies during an FDA inspection. Observations included inadequate aseptic process validation, failure to follow aseptic procedures, deficient environmental monitoring, and an inadequate visual inspection program. Additionally, the firm failed to maintain complete batch production records, lacked proper controls over computerized systems, and did not thoroughly investigate discrepancies or batch failures, indicating systemic quality control issues.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)

Company: https://www.keypedia.com/companies/penmix-ltd/812d8fd1-9ed5-4fc8-898a-57df3cd5ffd0

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3