# FDA 483 - Kutol Products Company, Inc. - March 03, 2020

Source: https://www.globalkeysolutions.net/records/483/kutol-products-company-inc/81aba56a-33e1-4a00-a48f-cd96e97ef2a1

> FDA 483 for Kutol Products Company, Inc. on March 03, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kutol Products Company, Inc.
- Inspection Date: 2020-03-03
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Kutol Products Co, a contract manufacturer in Sharonville, OH, received a Form 483 with seven observations during an inspection from February 20 to March 3, 2020. The inspection revealed significant deficiencies in quality systems, including repeat observations from 2015 regarding process validation and cleaning procedures for OTC antibacterial products. Other issues included inadequate investigations into micro deviations, poor equipment maintenance, insufficient employee training, improper component storage, and failure to follow complaint handling procedures.

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## Related Officers

- [Jon P. Antoniou](https://www.globalkeysolutions.net/people/jon-p-antoniou/e42f4f7d-dbdb-4d85-a755-92cb29c249bc)

Company: https://www.globalkeysolutions.net/companies/kutol-products-company-inc/0fa88356-5df6-440a-a60c-792dc11595a0

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22