# FDA 483 - CMIC CMO Korea Co., Ltd. - June 15, 2018

Source: https://www.globalkeysolutions.net/records/483/cmic-cmo-korea-co-ltd/ba17f28f-1d4d-4818-8b20-c55c47ae29fe

> FDA 483 for CMIC CMO Korea Co., Ltd. on June 15, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CMIC CMO Korea Co., Ltd.
- Inspection Date: 2018-06-15
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: CMIC CMO Korea Co., Ltd., an OTC drug manufacturer in Bucheon-si, Gyeonggi-do, received a Form 483 with six observations. The inspection revealed significant issues across quality control, laboratory operations, stability programs, employee training, and change control. These deficiencies indicate a lack of robust quality systems and data integrity concerns.

## Related Officers

- [Jose F. Velez](https://www.globalkeysolutions.net/people/jose-f-velez/0d1951e8-3aa5-48ff-bc54-1fae8a7a57c9)

Company: https://www.globalkeysolutions.net/companies/cmic-cmo-korea-co-ltd/e105da5b-263f-4765-b1be-b26d9fc05449

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1