FDA Inspection 1017373 — Diamond Wipes International Inc.
The FDA completed an inspection of Diamond Wipes International Inc. on August 9, 2017 in Bucyrus, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 9, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bucyrus, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |