FDA Inspection 585539 — Hologic, Inc.
The FDA completed an inspection of Hologic, Inc. on May 20, 2009 in Indianapolis, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 20, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |