FDA Inspection 809893 — NorMed
The FDA completed an inspection of NorMed on Dec 12, 2012 in Tukwila, WA. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 12, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tukwila, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 4336 | 21 CFR 211.150 | Written distribution procedure |