FDA Inspection 775448 — Nu-Gen Nutrition, Inc
The FDA completed an inspection of Nu-Gen Nutrition, Inc on Apr 9, 2012 in Troy, MI. 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
- Apr 9, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Troy, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |