# FDA 483 - C&T Dream Co., Ltd. - November 10, 2023

Source: https://www.keypedia.com/records/483/ct-dream-co-ltd/3efbfa7f-7143-47ef-ae25-edbef7a453de

> FDA 483 for C&T Dream Co., Ltd. on November 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: C&T Dream Co., Ltd.
- Inspection Date: 2023-11-10
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: C&T Dream Co., Ltd. in Cheonan, Korea, received a Form 483 with nine observations following an inspection of its pharmaceutical manufacturing facility. The inspection revealed significant deficiencies across multiple areas, including inadequate laboratory records, unvalidated manufacturing processes, lack of stability studies, and poor equipment maintenance. These issues indicate a broad failure to adhere to good manufacturing practices for their OTC drug product, "Walgreens, Dry Skin Healing Ointment."

## Related Documents

- [483 - 2023-11-10](https://www.keypedia.com/records/483/ct-dream-co-ltd/111f2ea2-a00e-4135-a4e4-26298eb9ce85)
- [WARNING_LETTER - 2023-11-10](https://www.keypedia.com/records/warning_letter/ct-dream-co-ltd/e2338ebd-fe37-4b1c-b90d-29bb80df2d8e)

## Related Officers

- [Robert J. Martin](https://www.keypedia.com/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)

Company: https://www.keypedia.com/companies/ct-dream-co-ltd/525b03d9-4161-4167-aff7-b528864d725a

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