FDA Inspection
Diamond Wipes International, Inc.Diamond Wipes International, Inc. – FDA Inspection, Nov 2, 2015
Record Details
This FDA Inspection record concerns Diamond Wipes International, Inc., with an inspection on November 2, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 2, 2015
- Product Type
- Drugs
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ID · 99448360-c0ea-4562-b02f-9f01116d4706
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 947970
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.130(c)Lot or control number assigned
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Diamond Wipes International, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| October 17, 2025 | VAI | Los Angeles District Office | Drug Quality Assurance |
| March 19, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 6, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 19, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 17, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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