FDA Inspection 882929 — Hello Life, Inc
The FDA completed an inspection of Hello Life, Inc on Jun 4, 2014 in Grand Rapids, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 4, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Grand Rapids, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15785 | 21 CFR 111.410(b) | Label, packaging - discrepancies |
| 15822 | 21 CFR 111.60(a) | Production, in- process control system design, master record |
| 15826 | 21 CFR 111.65 | Quality control - packaged, labeled |
| 16083 | 21 CFR 111.35(b)(6) | Documentation - equipment functions; intended use |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2621 | 21 CFR 211.198(b)(3) | Reason for Not Conducting Complaint Investigation |