FDA Inspection 577523 — Infrared Laboratories, LLC
The FDA completed an inspection of Infrared Laboratories, LLC on Apr 17, 2009 in Westfield, 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 17, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Westfield, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3288 | 21 CFR 820.90(b)(1) | Documentation of disposition, justification, signature |