FDA Inspection 1106707 — Surgi-Pak Inc.
The FDA completed an inspection of Surgi-Pak Inc. on October 17, 2019 in City Of Industry, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 17, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- City Of Industry, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2339 | 21 CFR 820.22 | Quality Audit/Reaudit - documentation |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |