FDA Inspection 949097 — Great Lakes Orthopedics, LLC
The FDA completed an inspection of Great Lakes Orthopedics, LLC on Oct 23, 2015 in Brookfield, WI. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 23, 2015
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Brookfield, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12338 | 21 CFR 1271.180(b) | Review and approval-responsible person |
| 12365 | 21 CFR 1271.195(d) | Documentation not maintained |