FDA Inspection 696907 — Velocity Pharma LLC
The FDA completed an inspection of Velocity Pharma LLC on November 12, 2010 in Melville, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 32 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 12, 2010
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Melville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1292 | 21 CFR 110.20(b)(1) | Sufficient space |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15525 | 21 CFR 111.30(b) | Equipment - automated - suitability |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15582 | 21 CFR 111.155(e) | Components - contamination, deterioration, mix-ups |
| 15584 | 21 CFR 111.155(d)(1) | Components - identify lot produced |
| 15585 | 21 CFR 111.155(d)(2) | Components - unique identifier |
| 15627 | 21 CFR 111.180(b)(3) | Documentation - product received; packaging, labeling |
| 15631 | 21 CFR 111.180(b)(3)(ii)(A) | Documentation - required operation; date received |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15733 | 21 CFR 111.365 | Manufacturing operations - prevent contamination |
| 15743 | 21 CFR 111.210(h)(3) | Master manufacturing record - specific actions; quality |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15766 | 21 CFR 111.430(a) | Records - packaging, labeling operations: 1 year, 2 years |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15864 | 21 CFR 111.75(a)(2)(ii)(C) | Documentation - qualify supplier |
| 15865 | 21 CFR 111.75(a)(2)(ii)(D) | Re-confirm certificate of analysis |
| 15872 | 21 CFR 111.75(c)(3) | Specifications met identity,purity, strength, comp,; basis |
| 15874 | 21 CFR 111.75(c)(4) | Documentation - specifications met; basis, quality control |
| 15908 | 21 CFR 111.90(b)(1) | Reprocessed, dietary supplement - no material review |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |
| 15972 | 21 CFR 111.120(b) | Quality control operations - specifications; components, packaging, labels |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |
| 16058 | 21 CFR 111.535(b)(2) | Records - ret'nd dietary supplement: material review, dispos |
| 16059 | 21 CFR 111.535(b)(3) | Returned dietary supplement: results; testing, examination |
| 16066 | 21 CFR 111.35(b)(1)(i) | Written procedures - instruments, controls; calibrating |
| 16074 | 21 CFR 111.35(b)(4) | Records - equipment; calibrations, inspections, checks |