FDA Inspection 1177119 — Vitality Works, Inc
The FDA completed an inspection of Vitality Works, Inc on August 5, 2022 in Albuquerque, NM. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 5, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Albuquerque, NM (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1223 | 21 CFR 211.67(b)(5) | Cleaning SOPs/equipment protection |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |