FDA Inspection 829251 — CURALLUX LLC
The FDA completed an inspection of CURALLUX LLC on May 16, 2013 in Doral, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 16, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14711 | 21 CFR 820.160(a) | Lack of or inadequate procedures for distribution |
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 5031 | 21 CFR 1010.2(a) | Lack of certification of conformance |
| 5044 | 21 CFR 1010.3(a)(2) | ID label lacks place, month & year of manufacture |
| 5199 | 21 CFR 1040.10(h)(1)(iii) | Legible reproductions |
| 5203 | 21 CFR 1040.10(h)(2)(i) | Reproduction of affixed information |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |
| 5811 | 21 CFR 1002.30(a)(1) | Quality control procedures |
| 5812 | 21 CFR 1002.30(a)(2) | Results of tests |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |