FDA Inspection 1017823 — 3M Company
The FDA completed an inspection of 3M Company on May 17, 2017 in Saint Paul, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 17, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Saint Paul, MN (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6832 | 21 CFR 314.80(c)(2) | Late submission of annual safety reports |
| 6842 | 21 CFR 314.80(j) | Failure to maintain records |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |
| 8923 | 21 CFR 314.81(b)(2) | Form FDA 2252 |
| 8936 | FDCA 760(b)(1) | No label copy submitted with AE report (non-Rx drug) |
| 8938 | FDCA 760(c)(1) | Timing of AE report submission (non-RX drugs) |
| 8939 | FDCA 760(c)(2) | New medical information, timing of submission (non-Rx drugs) |