FDA Inspection 785658 — DMX IMAGING, LLC
The FDA completed an inspection of DMX IMAGING, LLC on June 7, 2012 in Palm Harbor, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 17 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 7, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Palm Harbor, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 5005 | 21 CFR 1002.11 | Failure to submit |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |
| 5468 | 21 CFR 1020.30(j) | Mandatory warning on control panel |
| 5475 | 21 CFR 1020.30(m)(1) | Half-value layer--amount of filtration |
| 5687 | 21 CFR 1002.10(j) | Warning signs, labels, instructions |
| 5907 | 21 CFR 1020.30(d)(1) | Report of assembly submitted within 15 days |