# FDA 483 - CIT Co., Ltd. - December 08, 2023

Source: https://www.keypedia.com/records/483/cit-co-ltd/c32816ce-372e-4501-905a-2decc15b32fa

> FDA 483 for CIT Co., Ltd. on December 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CIT Co., Ltd.
- Inspection Date: 2023-12-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: CIT Co., Ltd. in Tangjin, Chungnam, Korea, a drug manufacturer, was inspected by the FDA from December 4-8, 2023. The inspection revealed significant deficiencies across multiple areas, including inadequate computer controls, insufficient stability testing, unvalidated test methods, lack of cGMP training for personnel, and failure to test for objectionable microorganisms in drug products. These issues indicate a broad lack of adherence to current Good Manufacturing Practices for OTC drug products intended for the U.S. market.

## Related Officers

- [Investigator](https://www.keypedia.com/people/sonya-m-edmonds/a38fad3f-f664-4c52-8e50-78782f56ff18)

Company: https://www.keypedia.com/companies/cit-co-ltd/ef09d591-2e37-438d-90c6-129f4c9ef8ed

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