FDA Inspection
Diamond Wipes International, Inc.Diamond Wipes International, Inc. – FDA Inspection, Sep 16, 2026
Record Details
This FDA Inspection record concerns Diamond Wipes International, Inc., with an inspection on September 16, 2026, issued by the Minneapolis District Office, covering human drugs.
- People
- Adele I. Werner (Issuing Officer)
- Joshua F. Blank (Issuing Officer)
- Justin A. Boyd (Investigator)
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ID · a8c52498-273c-44e2-a3e2-fcf9c1ea6fb2
Inspection Facts
- Inspection number
- 1336036
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.84(d)(2)Component written specification
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