FDA Inspection 1105439 — American Contract Systems, Inc.
The FDA completed an inspection of American Contract Systems, Inc. on October 4, 2019 in Houston, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 4, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |