FDA Inspection 1026492 — American Contract Systems, Inc.
The FDA completed an inspection of American Contract Systems, Inc. on May 11, 2017 in Waunakee, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 11, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Waunakee, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |