# FDA 483 - Diamond Wipes International, Inc. - September 06, 2019

Source: https://www.keypedia.com/records/483/diamond-wipes-international-inc/10c3912f-4276-44a4-8637-cd4ee4c9c5df

> FDA 483 for Diamond Wipes International, Inc. on September 06, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Diamond Wipes International, Inc.
- Inspection Date: 2019-09-06
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Diamond Wipes International, Inc. in Chino, CA, a medical device manufacturer, revealed two significant observations. The firm failed to establish adequate procedures for evaluating suppliers of bulk class II medical device products and for executing quality agreements with these suppliers. Additionally, the company lacked comprehensive written Medical Device Reporting (MDR) procedures to ensure timely and effective reporting of adverse events.

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## Related Officers

- [Maric I Alishahian](https://www.keypedia.com/people/maric-i-alishahian/bee777b3-aa5e-4a79-9426-bdc8f4d2e38a)
- [Sonya L. Karsik](https://www.keypedia.com/people/sonya-l-karsik/c24603b9-5ca0-46f5-861a-b367155b0def)

Company: https://www.keypedia.com/companies/diamond-wipes-international-inc/6f050515-bb8a-4538-9f81-e91f58a07397

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6