FDA Inspection 901039 — Multi-Clean
The FDA completed an inspection of Multi-Clean on Oct 23, 2014 in Shoreview, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 23, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Shoreview, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |