FDA Inspection 1012332 — Buzzagogo, LLC
The FDA completed an inspection of Buzzagogo, LLC on June 1, 2017 in Nottingham, NH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 1, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Nottingham, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1928 | 21 CFR 211.166(c)(1) | Homeopathic drugs, assessment of stability |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |