# FDA 483 - Diamond Wipes International, Inc. - March 19, 2021

Source: https://www.keypedia.com/records/483/diamond-wipes-international-inc/16c50757-18ce-4976-be9f-70072399bbb4

> FDA 483 for Diamond Wipes International, Inc. on March 19, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Diamond Wipes International, Inc.
- Inspection Date: 2021-03-19
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Diamond Wipes International, Inc. in Chino, CA, a drug manufacturer, revealed six significant deficiencies in their operations. The firm failed to establish adequate laboratory controls, maintain complete data, ensure data integrity in computerized systems, and properly manage quality control responsibilities. Additionally, investigations into product discrepancies were insufficient, and drug product labels were not stored in a controlled area, indicating serious compliance issues, including repeat deficiencies from prior inspections.

## Related Documents

- [WARNING_LETTER - 2017-05-17](https://www.keypedia.com/records/warning_letter/diamond-wipes-international-inc/56b991ce-9de7-4319-84e5-24f1fb7a89f0)
- [483 - 2019-04-19](https://www.keypedia.com/records/483/diamond-wipes-international-inc/bd57f57f-d87f-4a4b-b990-88cb82cc8952)
- [483 - 2019-09-06](https://www.keypedia.com/records/483/diamond-wipes-international-inc/10c3912f-4276-44a4-8637-cd4ee4c9c5df)
- [483 - 2025-10-17](https://www.keypedia.com/records/483/diamond-wipes-international-inc/fd49fdd7-5113-491d-af2c-f5e6783c9474)

## Related Officers

- [Investigator](https://www.keypedia.com/people/lisa-shin/13c87687-fe3d-41a5-8973-42be901a5b0c)
- [Uttaniti Limchumroon](https://www.keypedia.com/people/uttaniti-limchumroon/ce890cbf-2f5c-498f-917c-0edf8b10d356)

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