# FDA 483 - Diamond Wipes International, Inc. - April 19, 2019

Source: https://www.keypedia.com/records/483/diamond-wipes-international-inc/bd57f57f-d87f-4a4b-b990-88cb82cc8952

> FDA 483 for Diamond Wipes International, Inc. on April 19, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Diamond Wipes International, Inc.
- Inspection Date: 2019-04-19
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Diamond Wipes International, Inc. in Chino, CA, received a Form FDA 483 following an inspection from April 15-19, 2019. The inspection revealed two significant issues: the firm released drug products that failed seal integrity testing, and sanitation personnel did not consistently follow written procedures for equipment cleaning and sanitizing agent rotation. These observations indicate deficiencies in quality control and adherence to established manufacturing practices.

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## Related Officers

- [Senior CSO, Investigator](https://www.keypedia.com/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)
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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