# FDA 483 - Kobo Products, Inc - May 09, 2025

Source: https://www.globalkeysolutions.net/records/483/kobo-products-inc/71e53c3c-df3d-4919-bcad-9e9d0562adcb

> FDA 483 for Kobo Products, Inc on May 09, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kobo Products, Inc
- Inspection Date: 2025-05-09
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Kobo Products, Inc. in South Plainfield, NJ, an API manufacturer, was cited for four significant observations during an FDA inspection from May 2-9, 2025. The firm failed to establish adequate production and process controls, including process validation for Zinc Oxide and Titanium Dioxide API drug products. Additionally, issues were noted with equipment validation, cleaning validation, and computer system controls, specifically regarding unauthorized access and data alteration in the QC laboratory.

## Related Documents

- [483 - 2020-08-18](https://www.globalkeysolutions.net/records/483/kobo-products-inc/6c5ea614-2167-460c-aef1-a92bc1137cc9)

## Related Officers

- [Pharmacist | Consumer Safety Officer](https://www.globalkeysolutions.net/people/victoria-spivak/b43d066f-35c1-4d83-9d38-3ba64d77cf31)

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