FDA Inspection 1092083 — Velocity Production And Packaging
The FDA completed an inspection of Velocity Production And Packaging on May 8, 2019 in Tempe, AZ. 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). 9 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 8, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tempe, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1725 | 21 CFR 211.134(c) | Examinations documented |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |