# FDA 483 - Dae Young Foods Co., Ltd. - March 17, 2017

Source: https://www.globalkeysolutions.net/records/483/dae-young-foods-co-ltd/5ac5ff7c-9d8c-47f7-b7fb-0d829781bda9

> FDA 483 for Dae Young Foods Co., Ltd. on March 17, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dae Young Foods Co., Ltd.
- Inspection Date: 2017-03-17
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Bae Young Foods Co., Ltd., a homeopathic drug manufacturer in Boeun-gun, Korea, was cited for numerous significant deficiencies during an FDA inspection. The firm lacked essential written procedures for annual evaluations, reprocessing, and various production and process controls, indicating a severely underdeveloped quality system. Additionally, observations included inadequate testing of components and containers, poor maintenance of equipment and facilities, and failures in record-keeping and equipment identification.

## Related Documents

- [WARNING_LETTER - 2017-03-17](https://www.globalkeysolutions.net/records/warning_letter/dae-young-foods-co-ltd/7b036925-d8f9-4bbd-a8e4-ecf91a61c94f)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/nadeem-i-chaudhry/7d867939-2dc6-4503-b9b9-6f26b16c347e)

Company: https://www.globalkeysolutions.net/companies/dae-young-foods-co-ltd/cb2c7324-a2b6-4a79-8446-b2893dfb58b7

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321