FDA Inspection 744716 — H & A Mui Enterprises, Inc.
The FDA completed an inspection of H & A Mui Enterprises, Inc. on August 5, 2011 in Mississauga. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 5, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mississauga (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3270 | 21 CFR 820.80(c) | Documentation |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |