FDA Inspection 1136946 — Diamond Wipes International, Inc.
The FDA completed an inspection of Diamond Wipes International, Inc. on March 19, 2021 in Chino, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 19, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chino, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1416 | 21 CFR 211.42(c)(6) | Pkg / Labeling Operations Area |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |