FDA Inspection 911643 — Edwards Lifesciences Technology SARL
The FDA completed an inspection of Edwards Lifesciences Technology SARL on January 27, 2015 in Anasco, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 27, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Anasco, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 537 | 21 CFR 820.70(a) | Production processes |