FDA Inspection 606539 — American Contract Systems, Inc.
The FDA completed an inspection of American Contract Systems, Inc. on September 14, 2009 in Waunakee, WI. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 14, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Waunakee, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3271 | 21 CFR 820.80(d) | Quarantine of finished devices |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3417 | 21 CFR 820.70(a)(2) | Production monitoring and control |
| 4189 | 21 CFR 820.198(a) | General |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |