# FDA 483 - HK INNO.N CORPORATION - January 16, 2025

Source: https://www.keypedia.com/records/483/hk-innon-corporation/4c363a95-3238-4d17-8107-9ff7699fed96

> FDA 483 for HK INNO.N CORPORATION on January 16, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HK INNO.N CORPORATION
- Inspection Date: 2025-01-16
- Product Type: Drugs
- Office Name: Baltimore District Office
- Summary: The FDA conducted an inspection of HK inno.N Corporation, located in Heungdeok-gu, Cheongju-si, Chungbuk, Republic of Korea, from January 16 to January 24, 2025. The inspection revealed several critical violations concerning the manufacturing processes of sterile drug products. Key issues identified include inadequate validation of sterilization processes, insufficient justification for changes in sterilization parameters, and improper environmental monitoring in aseptic processing areas.

Specifically, the FDA noted that the procedures to prevent microbiological contamination lacked adequate validation, with discrepancies in sterility testing across sub-batches and cycles. Additionally, the firm failed to document the locations of sterility samples and did not include sterilization load monitors with each cycle. The holding times for certain processes were unspecified, and raw data was not properly documented and retained.

In terms of environmental monitoring, the company did not differentiate between dynamic and static conditions, leading to potential inaccuracies in particulate matter monitoring. Equipment malfunctions during dynamic conditions further compromised environmental monitoring reliability.

The FDA requires HK inno.N Corporation to address these violations by implementing corrective actions to ensure compliance with regulatory standards. This includes revising sterilization validation protocols, improving environmental monitoring practices, and ensuring comprehensive documentation and data retention. The company is encouraged to discuss objections or planned corrective actions with the FDA representatives or submit them to the FDA for review.

## Related Documents

- [483 - 2025-01-24](https://www.keypedia.com/records/483/hk-innon-corporation/f8ee28ed-d05e-46c1-97da-dc14ce00479a)

## Related Officers

- [Homero W. Aguilar](https://www.keypedia.com/people/homero-w-aguilar/fbc95655-a1a8-456f-a09a-7bc8a213a786)
- [Rowena S. Nguyen](https://www.keypedia.com/people/rowena-s-nguyen/ae39318e-1653-467c-94cc-26f8929441ac)
- [Drug National Expert](https://www.keypedia.com/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)

Company: https://www.keypedia.com/companies/hk-innon-corporation/a39c8108-81a3-4c86-8b70-8aace078ad85

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa