FDA Inspection 1019474 — Hologic, Inc.
The FDA completed an inspection of Hologic, Inc. on July 28, 2017 in Danbury, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 28, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Danbury, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5008 | 21 CFR 1002.20(a) | Failure to report |
| 5012 | 21 CFR 1003.10(a) | FDA not notified of defect or noncompliance |
| 5443 | 21 CFR 1020.30(g) | Providing adequate assembly information |
| 5811 | 21 CFR 1002.30(a)(1) | Quality control procedures |
| 5812 | 21 CFR 1002.30(a)(2) | Results of tests |