# FDA 483 - Cosmecca Korea Co., Ltd. - September 13, 2024

Source: https://www.keypedia.com/records/483/cosmecca-korea-co-ltd/38a9314c-b868-4c79-ae1d-42351a773034

> FDA 483 for Cosmecca Korea Co., Ltd. on September 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosmecca Korea Co., Ltd.
- Inspection Date: 2024-09-13
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Cosmecca Korea Co Ltd in Eumseong-gun, Chungcheongbuk-do, revealed ten significant observations regarding their drug product manufacturing operations. Key deficiencies included inadequate laboratory controls, insufficient computer system validation, unverified testing methods, and incomplete record-keeping. The firm also failed in supplier qualification, proper component sampling, process validation, and quality unit oversight, with several issues being repeat observations from a prior 2017 inspection.

## Related Documents

- [WARNING_LETTER - 2017-09-22](https://www.keypedia.com/records/warning_letter/cosmecca-korea-co-ltd/c6771901-bd6e-4bc4-8d90-8cd765ca0194)

## Related Officers

- [Paranthaman Senthamarai Kannan](https://www.keypedia.com/people/paranthaman-senthamarai-kannan/12221263-b29b-4696-9e6e-84e659ae43cd)
- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)

Company: https://www.keypedia.com/companies/cosmecca-korea-co-ltd/4253fe84-f4f3-408a-b837-8a095755674c

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