FDA Inspection 1156416 — Nice-Pak Products, LLC
The FDA completed an inspection of Nice-Pak Products, LLC on November 10, 2021 in Grand Rapids, MI. 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
- November 10, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Grand Rapids, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |