812234
Terve Sina Wellness Inc. — FEI 3000210902
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 12, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Marietta, GA (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 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 |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4414 | 21 CFR 211.204 | Record information maintained |