FDA Inspection 1141205 — Myerson LLC
The FDA completed an inspection of Myerson LLC on May 4, 2021 in Chicago, IL. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 4, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 734 | 21 CFR 803.50(b)(2) | Providing Incomplete or Missing Information |