FDA Inspection 993643 — Quincy Bioscience Holding Company Inc.
The FDA completed an inspection of Quincy Bioscience Holding Company Inc. on November 4, 2016 in Madison, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 4, 2016
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Madison, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15351 | FDCA 761(b)(1) | No AE report made (dietary supplement) |
| 15358 | FDCA 761(c)(1) | Timing of AE report submission (dietary supplement) |
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15680 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting, QC |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15709 | 21 CFR 111.325(b)(2) | Laboratory methodology followed |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15802 | 21 CFR 111.560(c) | Product complaint - review, investigation |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15867 | 21 CFR 111.75(b)(1) | Specifications met, in-process - quality finished batch |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |