FDA Inspection 794651 — Revvity Health Sciences Inc
The FDA completed an inspection of Revvity Health Sciences Inc on August 10, 2012 in Greenville, SC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 10, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Greenville, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3113 | 21 CFR 820.70(g) | Equipment design and installation |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4213 | 21 CFR 806.20(b)(5) | Records of communications |
| 537 | 21 CFR 820.70(a) | Production processes |