FDA Inspection 950519 — Moss Tubes Inc.
The FDA completed an inspection of Moss Tubes Inc. on November 12, 2015 in Castleton On Hudson, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 12, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Castleton On Hudson, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |
| 733 | 21 CFR 803.50(b)(1) | Reporting Information Reasonably Known |