# FDA 483 - Kovas Co., Ltd. - November 29, 2024

Source: https://www.keypedia.com/records/483/kovas-co-ltd/2f9ca0ae-4ebb-46e4-982a-60fa203185d6

> FDA 483 for Kovas Co., Ltd. on November 29, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kovas Co., Ltd.
- Inspection Date: 2024-11-29
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Kovas Co., Ltd. in Paju-si, Gyeonggi-do, Korea, an OTC drug product manufacturer, was inspected by the FDA and found to have significant deficiencies. The inspection revealed inadequate controls over computer systems, unsound laboratory test methods, incomplete laboratory and batch production records, and failures in quality control unit responsibilities and equipment maintenance. These issues indicate a systemic lack of adherence to Good Manufacturing Practices, posing risks to the identity, strength, quality, and purity of drug products.

## Related Documents

- [483 - 2019-11-22](https://www.keypedia.com/records/483/kovas-co-ltd/673e1c9c-42e7-411e-b53a-63f3b102f202)

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)

Company: https://www.keypedia.com/companies/kovas-co-ltd/3fa71e84-4ee0-4ce4-97e5-4d2b4e5e71d2

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