FDA Inspection 1021887 — American Contract Systems, Inc.
The FDA completed an inspection of American Contract Systems, Inc. on Apr 12, 2017 in Houston, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Apr 12, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |