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483
•Diamond Wipes International, Inc.•April 19, 2019

Diamond Wipes International, Inc. – FDA 483, Apr 19, 2019

Record Details

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.

Company
Diamond Wipes International, Inc.
Inspection date
April 19, 2019
Product type
drugs
Office
Division of Pharmaceutical Quality Operations IV
People
  • Santiago Gallardo Johnson (https://www.fda.gov/media/120628/download)
  • Nicholas L. Hunt (Senior CSO, Investigator)
View Company Profile

ID · bd57f57f-d87f-4a4b-b990-88cb82cc8952

Other documents for Diamond Wipes International, Inc.
  • 483 - 2025-10-17October 17, 2025
  • 483 - 2021-03-19March 19, 2021
  • 483 - 2019-09-06September 6, 2019
  • WARNING_LETTER - 2017-05-17May 17, 2017

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