FDA Inspection 949884 — Salt Chamber, LLC
The FDA completed an inspection of Salt Chamber, LLC on November 19, 2015 in Boca Raton, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 17 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 19, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Boca Raton, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3147 | 21 CFR 820.170(a) | Lack of or inadequate instructions |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |