FDA Inspection 648304 — Nice-Pak Products, Inc.
The FDA completed an inspection of Nice-Pak Products, Inc. on February 10, 2010 in Mooresville, IN. 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
- February 10, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mooresville, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |