FDA Inspection 1083552 — G&N Enterprise, LLC
The FDA completed an inspection of G&N Enterprise, LLC on March 22, 2019 in Jackson, MS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 22, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Over-the-Counter Drug Evaluation
- Location
- Jackson, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1496 | 21 CFR 211.122(a) | Sampling/testing of labeling/packaging materials |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |