FDA Inspection 1271788 — American Contract Systems Inc
The FDA completed an inspection of American Contract Systems Inc on June 2, 2025 in Tiffin, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 2, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tiffin, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3264 | 21 CFR 820.250(b) | Sampling methods - Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |