# FDA 483 - Hanmi Pharma Co., Ltd - February 01, 2018

Source: https://www.globalkeysolutions.net/records/483/hanmi-pharma-co-ltd/658a1814-5e4e-4311-9021-e5669c8c42d7

> FDA 483 for Hanmi Pharma Co., Ltd on February 01, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hanmi Pharma Co., Ltd
- Inspection Date: 2018-02-01
- Product Type: drugs
- Office Name: FDA District Office — Silver Spring, Unknown
- Summary: An FDA inspection of Hanmi Pharma Co., Ltd in Pyeongtaek-si, Korea, revealed inadequate document control procedures. Specifically, quality system document changes lacked consistent descriptions and sufficient documentation for adequate review prior to approval. This deficiency led to critical preventive maintenance checks being inadvertently removed from equipment checklists.

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## Related Officers

- [ Investigator ](https://www.globalkeysolutions.net/people/joseph-r-strelnik/1fb7d50e-abf2-45ef-85a8-71c61b33e42d)

Company: https://www.globalkeysolutions.net/companies/hanmi-pharma-co-ltd/0b8e461e-f4bd-46f3-bb96-2148bf40df3c

Office: https://www.globalkeysolutions.net/offices/fda-district-office-silver-spring-unknown/5b075d23-f009-4607-9522-94e8124c6d14