FDA Inspection 666778 — Medline Industries, LP
The FDA completed an inspection of Medline Industries, LP on May 12, 2010 in Arlington Heights, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 12, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Arlington Heights, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3162 | 21 CFR 820.184(b) | Quantity manufactured |
| 3687 | 21 CFR 820.100(a)(1) | Analysis of data sources |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |