1018711
Helena Laboratories, Corp. — FEI 1618982
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 21, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Beaumont, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |