FDA Inspection 1078554 — Chambermaid Products, Inc.
The FDA completed an inspection of Chambermaid Products, Inc. on Jan 31, 2019 in Melbourne, FL. 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). 14 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 31, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Melbourne, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3147 | 21 CFR 820.170(a) | Lack of or inadequate instructions |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 537 | 21 CFR 820.70(a) | Production processes |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |