# FDA 483 - Hanlim Pharm Co., Ltd. - April 24, 2026

Source: https://www.keypedia.com/records/483/hanlim-pharm-co-ltd/70949c33-dfe1-4dd8-9e0d-a37dfe740e9b

> FDA 483 for Hanlim Pharm Co., Ltd. on April 24, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hanlim Pharm Co., Ltd.
- Inspection Date: 2026-04-24
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Hanlim Pharm Co., Ltd., an OTC sterile drug manufacturer in Yonginsi, Korea, was cited for numerous significant deficiencies during an FDA inspection from April 16-24, 2026. The observations highlight severe issues in aseptic processing, including poor practices, inadequate validation, and environmental monitoring, many of which were repeat findings. Additionally, the firm failed to properly utilize stability data for expiration dates, maintain equipment, ensure data integrity, and validate analytical methods, indicating systemic quality control and manufacturing control failures.

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## Related Officers

- [Hung H. Do](https://www.keypedia.com/people/hung-h-do/580f78ba-ed7a-4c10-8f4c-a99d0af7206e)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.keypedia.com/companies/hanlim-pharm-co-ltd/2d7a6160-8193-4d7a-b9bd-569bfcbf933f

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