FDA Inspection 746143 — Custom Assemblies, Inc.
The FDA completed an inspection of Custom Assemblies, Inc. on September 1, 2011 in Pine Level, NC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 1, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pine Level, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3139 | 21 CFR 820.140 | Lack of or inadequate procedures for handling |
| 3237 | 21 CFR 820.72(b) | Remedial action |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |