FDA Inspection 749015 — Wisconsin Pharmacal Company
The FDA completed an inspection of Wisconsin Pharmacal Company on Oct 12, 2011 in Jackson, WI. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Oct 12, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Jackson, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 537 | 21 CFR 820.70(a) | Production processes |