FDA Inspection 768454 — Medical Supplies Corporation
The FDA completed an inspection of Medical Supplies Corporation on February 27, 2012 in Baltimore, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 27, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Baltimore, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 642 | 21 CFR 803.18(b)(1)(i) | Adverse events--all info not in file |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |