FDA Inspection 1012271 — Preservation Solutions, Inc.
The FDA completed an inspection of Preservation Solutions, Inc. on May 19, 2017 in Elkhorn, WI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 19, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Elkhorn, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3138 | 21 CFR 820.130 | Packaging |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3682 | 21 CFR 820.70(d) | Implementing Personnel Procedures, Health, Cleanliness. |
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |