FDA Inspection 587465 — Apothecary Products, Inc.
The FDA completed an inspection of Apothecary Products, Inc. on Jun 1, 2009 in Saint Charles, MI. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 1, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Saint Charles, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |