# FDA 483 - Kobo Products, Inc - August 18, 2020

Source: https://www.globalkeysolutions.net/records/483/kobo-products-inc/6c5ea614-2167-460c-aef1-a92bc1137cc9

> FDA 483 for Kobo Products, Inc on August 18, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kobo Products, Inc
- Inspection Date: 2020-08-18
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Kobo Products Inc. in South Plainfield, NJ, was inspected and cited for significant deficiencies across its laboratory, production, and quality systems. The firm failed to establish and document test method accuracy, maintain adequate computer controls for data integrity, and ensure complete laboratory records. Additionally, critical manufacturing operations lacked proper controls, quality unit responsibilities were not consistently followed, and no written stability testing program existed for OTC drug products.

## Related Documents

- [483 - 2025-05-09](https://www.globalkeysolutions.net/records/483/kobo-products-inc/71e53c3c-df3d-4919-bcad-9e9d0562adcb)

## Related Officers

- [Adetutu M. Gidado](https://www.globalkeysolutions.net/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)

Company: https://www.globalkeysolutions.net/companies/kobo-products-inc/998595c1-1a50-4600-8360-16c81c7e6d7b

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248