FDA Inspection 966077 — Nice-Pak Products, LLC
The FDA completed an inspection of Nice-Pak Products, LLC on March 23, 2016 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 23, 2016
- Fiscal Year
- 2016
- 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 |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |