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

Source: https://www.keypedia.com/records/483/kovas-co-ltd/bf68a121-e6b7-4e20-9fec-e3f9f34701e7

> 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: Baltimore District Office
- Summary: The FDA conducted an inspection of Kovas Co., Ltd., an OTC drug product manufacturer, from November 25 to November 29, 2024. The inspection resulted in an FDA Form 483 outlining eight significant observations regarding deviations from manufacturing quality standards. Main issues included inadequate controls over computer systems and laboratory instrumentation, raising concerns about data integrity, unauthorized access, and proper software validation. The company’s laboratory controls were found deficient, with scientifically unsound test methods, insufficient validation for product release and stability testing, and incomplete documentation for chemical and microbiological analyses. Additionally, Kovas Co., Ltd. failed to adequately verify supplier analyses for raw materials.

Further observations highlighted incomplete batch production records, a lack of comprehensive process validation, and several weaknesses within the Quality Control Unit, such as deficient procedures for data verification, deviation management, and out-of-specification investigations. The quality unit also released raw materials that did not meet specifications, and API supplier qualification processes were insufficient. Finally, observations noted inadequate cleaning and maintenance of manufacturing equipment, with visible residue and a lack of proper equipment logbooks. Kovas Co., Ltd. is required to implement comprehensive corrective and preventive actions to address these findings and ensure full compliance with regulatory requirements for drug manufacturing.

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

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa