FDA Inspection 911411 — Sound Healing Arts, PC dba Sound Healing Arts Center
The FDA completed an inspection of Sound Healing Arts, PC dba Sound Healing Arts Center on January 20, 2015 in University Place, WA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 20, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- University Place, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15602 | 21 CFR 111.160(e) | Packaging, labels - mix-ups |
| 15605 | 21 CFR 111.165(c) | Product received - quarantine |
| 15620 | 21 CFR 111.180(b)(1) | Written procedures - product received |
| 15779 | 21 CFR 111.415(a) | Clean, sanitize - filling, packaging equipment |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |